SPINE FUSION SENSOR

描述(申请人逐字填写)：脊柱融合术恢复 受疾病或创伤影响的脊柱的机械稳定性 两个或多个椎骨的机械结合。椎骨融合失败， 假关节，会引起术后疼痛和并发症。平均而言， 无创影像技术在脊柱肿瘤诊断中的准确性 假关节的发生率在59%到80%之间。目前，直接 手术探查是唯一100%可靠的融合诊断方法。 然而，脊柱内固定器械所承载的弯矩 在简单的屈曲-伸展试验中取决于融合器的硬度 脊椎元素。因此，通过测量脊柱元素的应变 固定器械，脊柱融合的质量可被评价为差 融合将可测量的应变传递到固定装置上，而完全融合 承受大部分载荷，只发生少量的载荷转移。评估……的状况 脊柱融合术我们提出了一种遥测、可植入的装置，它包括：(1) 固定在脊柱矫形固定器上的应变计传感器 在手术过程中常规植入，以及(2)无源电子电路(打开 需要电源)，用于测量和无线数据传输至 外面的读者。该诊断设备利用成熟的技术 产生可靠和准确诊断的新应用。 建议的商业应用： 在美国，每年有超过247,000例融合手术和275,000例椎间盘摘除手术。世界范围内， 这一数字是脊柱手术设备市场增长的两倍多 估计超过20%，而脊柱融合手术的增长率一直在 估计超过10%。全球脊柱固定器械市场达到了 1999年估计为11亿美元，并以每年约15%的速度增长。 所设计的传感器将显著降低手术后随访的成本。 患者治疗的改善和成本的降低将是主要后果 在脊柱融合监测方面的这一创新。

DESCRIPTION (Verbatim from Applicant): Spine fusion procedures restore mechanical stability to a spinal column affected by disease or trauma by mechanical integration of two or more vertebrae. Failure to fuse the vertebra, pseudarthrosis, causes post operative pain and complications. On average, the accuracy of non-invasive imaging techniques in diagnosis of spinal pseudarthrosis is in the range of 59 percent to 80 percent. Currently, direct surgical exploration is the only 100 percent reliable fusion-diagnostic method. However, the bending moment carried by the spinal fixation instrumentation during simple flexion-extension tests depends on the stiffness of the fused spine elements. Therefore, by measuring strain in the elements of the spine fixating instrument, the quality of spine fusion can be evaluated as poor fusion transfers measurable strain onto the fixating device whereas full fusion bears most the load and only minor load transfer occurs. To evaluate status of spinal fusion we propose a telemetric, implantable device that consists of: (1) strain gauge sensor attached to the orthopeadic spine fixator; a device routinely implanted during surgery, and (2) passive electronic circuit (no "on board" power source required) for measurement and wireless data transmission to an outside reader. This diagnostic device utilizes established technologies for new applications producing reliable and accurate diagnosis. PROPOSED COMMERCIAL APPLICATION: Over 247,000 fusions and 275,000 discectomies is performed in U.S. each year. Worldwide, the numbers are more than double Market growth for devices used in spine surgery has been estimated at more than 20%, while the growth rate for spine fusion procedures has been estimated at more than 10%. The worldwide spinal fixation devices market reached an estimated $1.1 billion in 1999 and is growing at approximately 15% per year. The designed sensor will result in significant reduction of cost of post surgical follow-ups. Improvement in patient treatment and the reduction of cost will be the major consequences of thisinnovation in spine fusion monitoring.