Development of an Osteoinductive Spinal Fusion Implant for Enhanced Fusion Rates

项目摘要 本II期SBIR的目的是测试骨诱导腰椎间盘突出症的安全性和有效性。 绵羊模型中的融合植入物。在初步工作中，低阻抗压电材料， 制造了用于直流（DC）电刺激应用的电源，并且机电地 表征了在骨诱导脊柱融合植入物设计中，绝缘压电复合材料充当骨诱导材料。 电源发生器，用于向安装在电极上的钛电极提供负DC电刺激。 植入物的表面。在第一阶段STTR研究中，一种更具成本效益和机械合理的方法， 使用易于使用的环氧材料开发了压电腰椎融合植入物的制造。 Evoke Medical已经建立了战略合作伙伴关系，这将使我们能够设计，构建和测试基于PEEK的 压电椎体间植入物可以以合理的成本大量制造。 在腰椎融合术中，已发表研究报告的成功率约为50- 90%。这 不一致主要是由于大量难以融合的患者（例如，吸烟者、糖尿病患者）。DC电 刺激已被证明有助于提高难以融合人群的成功率，并加速 所有患者的骨愈合率。使用封装的压电材料进行的初步大型动物研究 复合材料脊柱融合植入物显示其在脊柱融合中可产生更快和更好的愈合。而 初步研究显示出巨大的前景，这个概念必须用PEEK植入物来证明，并进行测试 有足够数量的动物来显示统计学差异。 第二阶段建议的前提是， 具有集成DC刺激的椎体间植入物将促进更快和更坚固的脊柱融合， 与大型动物模型中的当前护理标准进行比较。凭借高性价比的制造技术， 在第二阶段的安全性和有效性的方法和证明，Evoke医疗可以继续前进， 这种潜在的破坏性技术的商业化可能最终会提高脊柱手术的成功率。 在难以融合的人群中融合。 在具体目标1中，我们将实施制造基于PEEK的堆叠分层的成本效益方法。 压电复合TLIF植入物，在第一阶段的工作中开发。在第二章中，我们将证明 基于PEEK的压电TLIF植入物可以满足或超过法律规定的机械要求 市售TLIF同品种器械使用推荐的ASTM标准进行椎体间测试，同时保持 能够产生足够的能量来愈合骨骼。在具体目标3中，我们将证明安全性和 压电TLIF植入物在绵羊模型中的有效性。这项工作的结果将为以下方面奠定基础： 早期临床试验的III期资助需要获得监管许可，随后被大型制药公司收购。 医疗器械公司。胸腰椎椎间融合器市场超过13亿美元/年， 年增长率为5.6%。假设申报器械可增加愈合成功率， 减少治愈时间，从而降低护理的总成本和人类痛苦。

PROJECT SUMMARY The objective of this Phase II SBIR is to test the safety and efficacy of an osteoinductive lumbar spinal fusion implant in an ovine model. In preliminary work, lower impedance piezoelectric materials that generate power for direct current (DC) electrical stimulation applications were manufactured and electromechanically characterized. In an osteoinductive spinal fusion implant design, an insulated piezoelectric composite acts as a power generator to supply negative DC electrical stimulation to a Titanium electrode that is mounted on the surface of the implant. In the Phase I STTR research, a more cost-effective and mechanically sound method of manufacturing the piezoelectric lumbar spinal fusion implant was developed using easy to use epoxy materials. Evoke Medical has formed strategic partnerships that will allow us to will design, build, and test PEEK-based piezoelectric interbody implants that can be manufactured in volume at a reasonable cost. In lumbar spine fusion, the success rate reported in published studies ranges from approximately 50-90%. This disparity is primarily due to the high number of difficult-to-fuse patients (e.g., smokers, diabetics). DC electrical stimulation has been shown to help increase success rates in the difficult-to-fuse population and accelerate the rate of bone healing in all patients. Preliminary large animal studies using an encapsulated piezoelectric composite spinal fusion implant showed that it could generate faster and better healing in spine fusion. While preliminary studies show great promise, the concept must be proven with PEEK-based implants and tested with sufficient numbers of animals to show statistical differences. The premise of the Phase II proposal is that an interbody implant with integrated DC stimulation will promote a faster and more robust spinal fusion in comparison to the current standard of care in a large animal model. With the cost-effective manufacturing methods and demonstration of safety and efficacy in Phase II, Evoke Medical can then move forward with commercialization of this potentially disruptive technology that may eventually increase success rates of spinal fusion in the difficult to fuse populations. In Specific Aim 1, we will implement the cost-effective methods of manufacturing stacked layered PEEK-based piezoelectric composite TLIF implants that were developed in the Phase I work. In Specific Aim 2, we will prove that the PEEK-based piezoelectric TLIF implants can meet or exceed mechanical requirements of a legally marketed TLIF predicate device using recommended ASTM standards for interbody testing while maintaining the ability to produce sufficient power for bone healing. In Specific Aim 3, we will demonstrate safety and efficacy of the piezoelectric TLIF implant in an ovine model. The results of this work will set the stage for Phase III funding of early clinical trials required for regulatory clearance and subsequent acquisition by a large medical device company. The thoracolumbar spine interbody market is over $1.3B/year with a compound annual growth rate of 5.6%. The proposed device is hypothesized to increase the success of healing and decrease the time to heal, thus decreasing overall cost of care and human suffering.