Feasibility of Non-surgical Implant Adjustment

描述（由申请人提供）：虽然微创手术已经改变了手术实践，但取出或改变植入物仍然需要手术，这会产生风险和高成本。下一代方法是非侵入性的，其中植入物在没有切口的情况下进行调整。在外科手术的所有领域都有明确的应用，但特别是在骨科手术中，植入物需要经常调整。其中一种情况，即早发性脊柱侧凸，是造成高成本和患者预后不良的主要原因。脊柱侧凸是脊柱的病理性侧弯大于10，影响2-4%的人口，或在美国估计有600万人。如果不及时治疗，早发性脊柱侧凸可导致 在生命早期破坏脊柱畸形;从而影响儿童健康的其他方面。对于早发性特发性脊柱侧凸没有已知的治疗方法。早期脊柱侧凸最常见的手术治疗是使用生长棒。在该手术中，每隔6个月延长一次矫形棒，以保持脊柱畸形的矫正和控制，并适应和促进脊柱/胸椎生长而不融合。研究报告称，儿童手术时的平均年龄为4.5岁，每位患者的平均手术次数为9.3次。所提出的新技术基本上执行与现有技术（生长棒）相同的功能。然而，现有的治疗需要每6个月进行一次侵入性手术，以通过螺丝刀进入并拧紧螺塞，而Apto器械使用旋转磁铁无创地调节螺塞。这种非侵入性调整的结果是转型-无需手术即可延长结构的能力。这有明显的潜力，既显着改善患者的结果，并显着降低医疗成本。对于最近被诊断为早发性脊柱侧凸的6岁儿童（及其父母）来说，他/她整个童年每六个月就要接受一次手术的前景令人生畏。提出的解决方案承诺给这些儿科患者一个充满学习，活动和乐趣的童年-而不是 持续恢复或准备脊柱手术。我们的长期目标是将非侵入性可调节植入物商业化，这种植入物有可能提供上级结局，同时降低护理成本。本提案的目的是证明非侵入性调整生长棒长度用于治疗早发性脊柱侧弯的可行性。我们计划通过解决以下三个具体目标来实现我们提案的总体目标：1）证明器械的生物相容性; 2）证明器械植入活体动物的可行性; 3）证明在2个时间点无创延长生长杆的可行性。完成本提案将证明骨科植入物无创调整的可行性。

DESCRIPTION (provided by applicant): While minimally invasive surgery has transformed the practice of surgery, access to implants for removal or alteration still requires surgery which generates risk and high cost. A next-generation approach is non-invasive, where implants are adjusted without an incision. There are clear applications in all fields of surgery, but particulary in orthopaedics where implants require frequent adjustment. One condition, early onset scoliosis, is disproportionally responsible for high cost and poor patient outcomes. Scoliosis, a pathological lateral curvature of the spine greater than 10, affects 2-4% of the population, or an estimated 6 million people in the United States. If left untreated, early onset scoliosis can cause damaging spinal deformity early in life; thus affecting other aspects of the child's health. There s no known cure for early onset idiopathic scoliosis. The most common surgical treatment of early onset scoliosis utilizes growing rods. In this procedure, rods are lengthened at 6 month intervals to maintain correction and control of the spinal deformity and to accommodate and facilitate spinal / thoracic growth without fusion. Studies have reported the mean age of the child at surgery to be 4.5 years with a mean number of procedures per patient was 9.3. The proposed novel technology performs essentially the same function as existing technology (growing rods). However, whereas the existing treatment requires invasive surgery every 6 months to access and tighten the set screw by a screwdriver, the Apto device adjusts the set screws non-invasively using a rotating magnet. The result of this non-invasive adjustment is transformational - the ability to lengthen the construct without surgery. This has the clear potential to both significantly improve patient outcomes and to significantly decrease healthcare costs. To the 6-year old (and his/her parents) recently diagnosed with early onset scoliosis, the prospect of facing surgery every six months for his/her entire childhood is daunting. The proposed solution promises to give these pediatric patients a childhood filled with learning, activity, and fun - not constant recovery or preparation for spinal surgery. Our long-term goal is to commercialize non-invasively adjustable implants, which have the potential to provide superior outcomes while reducing the cost of care. The objective of this proposal is to demonstrate the feasibility of non-invasively adjusting the length of growing rods for the application of early onset scoliosis. We plan to achieve our proposal's overall goals by addressing the following three specific aims: 1) Demonstrate the biocompatibility of the device; 2) Demonstrate the feasibility of implantation of the device in a living animal; and 3) Demonstrate the feasibility of non-invasive lengthening of growing rods at 2 time points. Completion of this proposal would demonstrate the feasibility of non-invasive adjustment of an orthopaedic implant.