Spinal Fusion Implant with Embedded Biomechanically Powered Sensor

带有嵌入式生物力学驱动传感器的脊柱融合植入物

• 批准号: 10603735
• 负责人: Leighton LaPierre
• 金额: $ 27.49万
• 依托单位: EVOKE MEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10603735
• 关键词: Area; Back; Back Pain; Biofeedback; Biomechanics; Bone Growth; Bone structure; COVID-19; Calibration; Clinical; Collection; Computer software; Custom; Data; Development; Devices; Electric Stimulation; Electrodes; Ensure; Environment; Excision; Failure; Frequencies; Funding; Future; Goals; Growth; Harvest; Health Care Costs; Health Personnel; Human; Human body; Image; Implant; In Situ; Industry; Linear Regressions; Measures; Mechanics; Medical; Methods; Miniaturization; Monitor; Motion; Office Visits; Operative Surgical Procedures; Outcome; Outcome Measure; Output; Pain; Patient Care; Patient Outcomes Assessments; Patient Self-Report; Patient-Focused Outcomes; Patients; Persons; Phase; Physicians; Physiologic pulse; Physiological; Population; Postoperative Period; Process; Publishing; Reporting; Risk; Risk Reduction; Rural; Safety; Sheep; Signal Transduction; Site; Small Business Innovation Research Grant; Smoker; Spinal; Spinal Fusion; Surface; Surgeon; Technology; Testing; Texture; Time; Translating; Validation; Vertebral column; Visit; Walking; Work; X-Ray Computed Tomography; X-Ray Medical Imaging; base; biomaterial compatibility; bone; bone healing; care costs; commercialization; conditioning; cost; cost effective; data acquisition; data exchange; data tools; design; diabetic; early phase clinical trial; electric impedance; experience; healing; health care availability; implantable device; improved; in vivo; mechanical load; medical implant; miniaturize; mobile application; prevent; prototype; sensor; simulation; success; verification and validation; voltage; wireless

PROJECT SUMMARY The objective of this Phase I SBIR is to develop a spinal fusion implant with embedded biomechanically powered sensor. Evoke Medical’s core technology is to create human-powered implantable devices that utilize piezoelectric materials to generate load-induced power. That power can then be used for various purposes: electrical stimulation of bone growth and/or load-sensing to track fusion progression. Through our current Phase II project, a fully integrated piezoelectric transforaminal lumbar interbody fusion (TLIF) implant was developed with embedded power generator and miniaturized circuitry for signal conditioning. In this TLIF implant, lower impedance piezoelectric materials were used to generate power for mechanically synced direct current (DC) electrical stimulation delivered to an electrode on the implant surface for the purposes of enhancing bone growth. No batteries are used in any Evoke Medical implant as all energy is biomechanically induced by human motion. Our preliminary work has also shown that a piezoelectric interbody implant can act as a sensor and distinguish between different applied physiological loads that correlate to fusion progression. In other industries, piezoelectric materials are often used as load sensors. In situ, mechanical loads applied to the piezoelectric device generate proportional electrical voltages that can be translated back to quantify the applied load on the device. Evoke Medical will use this inherent ability of piezoelectric materials to characterize the change in load environment within the disc space, and subsequently provide objective data to the clinician and patient to inform post-operative outcomes and treatment decisions. In spinal fusion, the load on the implant is highest when the device is first implanted and there is no bony fusion mass around and throughout the implant. As fusion progresses, the load on the implant is reduced according to the fusion grade achieved due to the increased surface area and stiffness of the growing bone structure. In this proposal, we will prove that a custom piezogenerator embedded in a spinal fusion implant with the associated circuit hardware and data acquisition software can collect, store, and wirelessly transmit changes in load within the interbody space. These changes can then be related back to fusion progression and other post-operative outcomes. Evoke Medical has already developed cost-effective manufacturing methods and demonstration of safety and efficacy of the stimulating aspect of the piezoelectric TLIF that is moving forward in the commercialization process through a DeNovo regulatory strategy. In these verification tests, we have also proven that we can successfully harvest patient motion and convert that to usable power under physiological loading conditions. By developing the load sensing aspect of the TLIF implant now, Evoke Medical will be able to jumpstart our capabilities to provide patients with biofeedback on how their implant is helping them. It will give surgeons the ability to quantify healing progress without the multitude of expensive CT scans or potentially biased patient reported outcome measures. This will allow the physician to make informed postoperative treatment decisions that could greatly improve the chances of fusion success. Commercialization of this remote load sensing data tool for spinal fusion patient care is disruptive, will help to reduce healthcare costs, and simultaneously enhance patient care, particularly in rural or remote areas or in times of limited access to healthcare providers (e.g. during COVID-19). In this Phase 1 project, we will first establish that utilizing a textured piezogenerator embedded in a TLIF implant will power the necessary components in a prototype load sensing circuit. The functionality of integrating the developed sensor circuit with a data acquisition framework will be verified through a large range of applied physiologic load conditions. Proving that the Evoke piezoelectric TLIF can accurately sense and output physiologic load data, differentiating between varying loads expected in fusion progression, will de-risk the integration of sensing and bone stimulating capabilities. The results of this work will set the stage for Phase II funding to integrate and miniaturize the sensing and stimulating circuits to create an integrated, dual mode stimulating and sensing spinal fusion implant. As part of this phase II work, additional in vivo validation ovine studies will be completed to justify moving forward with commercialization. Following, additional funding will be raised to complete the necessary verification & validation testing along with early clinical trials required for expanded regulatory claims around addition of the sensing capability of the TLIF implant. The thoracolumbar spine interbody market is over $1.4B/year with a compound annual growth rate of 2.9%. The proposed device is hypothesized to increase success of healing and decrease time to heal, as well as give patients and healthcare providers quantitative outcome measures without expensive CT scans or biased patient self-reporting. This would decrease overall cost of care and human suffering, as earlier, data driven post-operative decisions could be made, preventing a failed fusion and additional revision surgeries.

项目摘要 本阶段SBIR的目的是开发一种脊柱融合植入物， 动力传感器Evoke Medical的核心技术是创造人力植入设备， 压电材料以产生负载感应功率。这种力量可以用于各种目的： 骨生长的电刺激和/或负荷感测以跟踪融合进展。通过我们目前的阶段 II项目，开发了一种完全集成的压电经椎间孔腰椎椎间融合（TLIF）植入物 具有嵌入式发电机和用于信号调节的小型化电路。在该TLIF植入物中， 阻抗压电材料用于产生机械同步直流电（DC）的功率， 为了增强骨生长的目的，将电刺激传递到植入物表面上的电极。 任何Evoke Medical植入物均未使用电池，因为所有能量均由人体运动通过生物力学诱导产生。 我们的初步工作还表明，压电椎间植入物可以作为传感器， 与融合进展相关的不同施加生理负荷之间的差异。 在其他行业中，压电材料通常用作负载传感器。在现场，机械载荷施加到 压电装置产生成比例的电压，该电压可以被转换回来以量化 在器械上施加载荷。Evoke Medical将利用压电材料的这种固有能力来表征 椎间隙内载荷环境的变化，并随后向临床医生提供客观数据 和患者，以告知术后结果和治疗决策。在脊柱融合术中，植入物上的载荷 当首次植入器械且植入物周围和整个植入物中没有骨融合块时， 随着融合的进行，植入物上的载荷根据由于融合而达到的融合等级而减小。 增加的表面积和生长的骨结构的硬度。在这个例子中，我们将证明， 嵌入在具有相关电路硬件的脊柱融合植入物中的定制压电发生器， 数据采集软件可以收集、存储和无线传输椎体间载荷的变化 空间然后，这些变化可以与融合进展和其他术后结果相关。 Evoke Medical已经开发出具有成本效益的制造方法，并证明了安全性和 压电TLIF刺激方面的有效性，正在商业化中向前发展 通过DeNovo监管策略进行流程。在这些验证测试中，我们还证明了我们可以 成功采集患者运动并将其转换为生理负载条件下的可用功率。通过 Evoke Medical现在正在开发TLIF植入物的负载感应方面， 能够为患者提供植入物如何帮助他们的生物反馈。它将给外科医生 能够量化愈合进展，无需大量昂贵的CT扫描或潜在的患者偏见 报告的结果测量。这将使医生作出知情的术后治疗决定 可以大大提高核聚变成功的几率这种远程负载传感数据的商业化 脊柱融合患者护理的工具是破坏性的，将有助于降低医疗成本，同时提高 患者护理，特别是在农村或偏远地区或在医疗保健提供者有限的时间（例如， COVID-19）。 在该第1阶段项目中，我们将首先确定利用嵌入TLIF植入物中的纹理压电发生器 将为原型负载感测电路中的必要组件供电。集成的功能 开发的传感器电路与数据采集框架将通过大范围的应用验证 生理负荷条件。证明Evoke压电TLIF能够准确感知和输出 生理负荷数据可以区分融合进展中预期的不同负荷，这将降低融合的风险。 传感和骨刺激能力的集成。 这项工作的结果将为第二阶段的资助奠定基础，以整合和实现传感和 刺激电路以产生集成的双模式刺激和感测脊柱融合植入物。的一部分 在II期工作中，将完成额外的绵羊体内验证研究，以证明继续进行 商业化随后，将筹集额外资金，以完成必要的验证和确认 测试沿着早期临床试验，这些试验需要扩大关于增加传感的监管声明 TLIF植入物的性能。胸腰椎椎间融合器市场超过14亿美元/年， 年增长率为2.9%。假设申报器械可增加愈合成功率， 治愈时间，以及为患者和医疗保健提供者提供定量结果测量，而无需昂贵的 CT扫描或有偏见的患者自我报告。这将减少护理和人类痛苦的总成本， 在早期，可以做出数据驱动的术后决策，防止融合失败和额外的翻修 手术