R-FIX (Rib-FIXation System) for Severe Progressive Spinal Deformity: I-Corps Supplement

项目摘要 脊柱畸形是一个极具挑战性的临床问题。曲度可以在侧方(脊柱侧弯)、前方 方向(后凸过度)或两者兼而有之(脊柱后凸)。早发性脊柱畸形(EOSD)是一种始于 在10岁之前。手术矫正通常包括用棒和椎弓根螺钉对齐脊柱。 不幸的是，接受脊柱畸形手术的患者经历了高度的内固定相关。 并发症发生率，这对预后产生了负面影响，限制了畸形矫正，特别是在 涉及EOSD或成人后凸畸形。其中一些并发症包括失去近端内固定(椎弓根 螺钉拔出)、棒断裂、近端交界性后凸(PJK)和神经损伤。此应用程序 提出了一种称为肋骨结构的新技术，用于矫正脊柱畸形，特别是在涉及 EOSD或严重的成人后凸畸形。肋骨结构不是用椎弓根螺钉将棒固定在脊柱上，而是 使用一系列钩子将近端固定移到肋骨上。这种方法是一种观念上的转变 脊柱畸形，即胸部被操纵以二次重新定位脊柱。肋骨构造允许 外科医生可以在矢状面、冠状面和轴面的任意组合中操作胸腔，允许更安全， 更有效、更全面的畸形矫正。肋骨与肋骨结构的固定可通过以下任一方法实现： 1)标签外的椎板钩，这种钩已经在商业上可以用于椎板的脊柱固定，但也可以 作为我们新型专利R-FIX(肋骨固定系统)的一部分，可用于肋骨或2)肋骨钩。而层流 在我们的初步临床应用中，与椎弓根螺钉相比，钩的表现更好。 完全在标签外使用，目前还没有为这项技术设计的商业手术系统。那里 在扭力作用下失去固定，内固定物突出，偶尔还会出现肋骨骨折。 用层状钩子折断。R-FIX系统起源于一个生物工程实验室(申请人之一的 Labs)，并由Apex Orthopedic Technologies进一步开发，旨在 解决这些问题。这个母公司SBIR奖的目标有三个：1)完成设计和 R-FIX系统的制造，2)通过以下方式证明肋骨固定的总体概念 获得基础科学数据以支持我们已经获得的临床数据，以及3)展示 与层状挂钩相比，R-FIX肋形挂钩的性能更优越。我们的团队寻求加入i-Corps 计划从行业领导者那里获得关于监管战略、知识产权战略、最终用户需求、 制造和销售。在I-Corp计划期间制定的业务计划将用于SBIR 第二阶段将于2023年9月提交。参与这一i-Corp计划将有额外的好处 提供一个有前途的年轻的医学博士候选人和未来的整形外科医生，以及一个优秀的 未来的神经外科医生，在医疗器械开发的翻译方面进行额外的培训。每个人 这个团队的成员对参与i-Corp计划充满热情。

Project Summary Spinal deformity is a challenging clinical problem. Curvature can be in the lateral direction (scoliosis), anterior direction (hyperkyphosis) or both (kyphoscoliosis). Early-onset spinal deformity (EOSD) is deformity that begins before 10 years of age. Surgical correction typically involves aligning the spine with rods and pedicles screws. Unfortunately, patients undergoing surgery for spinal deformity experience high instrumentation-related complication rates, which negatively impact outcomes and limit deformity correction, especially in cases that involve EOSD or adult hyperkyphosis. Some of these complications include loss of proximal fixation (pedicle screw pull-out), rod breakage, proximal junctional kyphosis (PJK), and neurologic injury. This application proposes a new technique called the rib construct for correcting spinal deformity, especially in cases that involve EOSD or severe adult hyperkyphosis. Instead of anchoring rods to the spine with pedicle screws, the rib construct moves proximal fixation to the ribs using a series of hooks. This approach is a conceptual shift in approaching spinal deformity, in that the thorax is manipulated to secondarily reposition the spine. The rib construct allows the surgeon to manipulate the thorax in any combination of sagittal, coronal, and axial planes, allowing for safer, more effective, and versatile deformity correction. Rib fixation with the rib construct can be achieved with either: 1) off-label laminar hooks, which are already commercially available for spinal fixation to the lamina but can also be used on the ribs, or 2) rib hooks as part of our novel patented R-FIX (Rib-FIXation System). While laminar hooks have performed favorably compared to pedicle screws in our preliminary clinical use, these have been used entirely off-label and there is no commercially available surgical system designed for this technique. There have been issues with loss of fixation under torsional forces, implant prominence, and occasional cases of rib fracture with laminar hooks. The R-FIX System, which originated from a bioengineering lab (one of the applicants' labs) at Clemson University and has been further developed by Apex Orthopaedic Technologies, is designed to resolve these issues. The objective of this parent SBIR award is threefold: 1) to complete the design and manufacturing of the R-FIX System, 2) to prove the overall concept of rib fixation with the rib construct by obtaining basic science data to support the clinical data we have already obtained, and 3) to demonstrate the superior performance of R-FIX rib hooks compared to laminar hooks. Our group seeks to join the I-Corps Program to gain input from industry leaders on topics including regulatory strategy, IP strategy, end user needs, manufacturing, and sales. The business plan formulated during the I-Corp Program will be used in an SBIR Phase II submission in September 2023. Participation in this I-Corp Program would have the added benefit of providing a promising young MD-PhD candidate and prospective orthopedic surgeon, as well as an up-and- coming neurosurgeon, with additional training in the translational aspects of medical device development. Each member of this team is enthusiastic about participation in the I-Corp Program.