SPINE FUSION SENSOR

脊柱融合传感器

• 批准号: 6337842
• 负责人: JAN JERZY LEWANDOWSKI
• 金额: $ 12.83万
• 依托单位: ELECTROSONICS MEDICAL INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-06-01 至 2002-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6337842
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; bone prosthesis; human tissue; implant; intervertebral disk surgery; medical implant science; monitoring device; spinal fusion; telemetry

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.

描述（来自申请人的逐字描述）：脊柱融合手术恢复 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。脊椎融合失败 假关节，导致术后疼痛和并发症。平均下来 无创性影像学技术诊断脊髓损伤的准确性 假关节在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，脊柱固定器械所承载的弯矩 在简单的屈伸测试中， 脊柱元素。因此，通过测量脊柱各部分的应变 固定器械，脊柱融合质量可评价为差 融合将可测量的应变传递到固定装置上 承受大部分载荷，仅发生较小的载荷转移。评估状态 脊柱融合术我们提出了一种遥测的可植入装置，包括：（1） 连接到骨科脊柱固定器的应变计传感器;一种器械 在手术过程中常规植入，和（2）无源电子电路（无“开启”） 板”所需的电源）进行测量和无线数据传输， 一个局外读者。该诊断设备利用现有技术， 新的应用产生可靠和准确的诊断。 拟定商业应用： 美国每年进行超过247，000例融合术和275，000例椎间盘切除术。 在世界范围内， 这些数字是两倍多，用于脊柱手术的器械的市场增长一直是 估计超过20%，而脊柱融合手术的增长率一直是 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。 所设计的传感器将导致手术后随访的成本显着降低。 改善病人的治疗和降低成本将是主要的结果 of thisinnovation创新in spine脊柱fusion融合monitoring监测.