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

R-FIX（肋骨固定系统）用于治疗严重进行性脊柱畸形：I-Corps 补充剂

• 批准号: 10772940
• 负责人: Richard H. Gross
• 金额: $ 5.5万
• 依托单位: APEX ORTHOPAEDIC TECHNOLOGIES LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10772940
• 关键词: 10 year old; Adult; Anterior; Apical; Award; Basic Science; Biomedical Engineering; Businesses; Chest; Clinical; Clinical Data; Complication; Data; Deformity; Device or Instrument Development; Doctor of Philosophy; Grant; Hyperkyphosis; Implant; Industry; Innovation Corps; Kyphosis deformity of spine; Label; Lateral; Legal patent; Marketing; Medical Device; Nervous System Trauma; Neurosurgeon; Operative Surgical Procedures; Orthopedics; Osteoporotic; Outcome; Parents; Patients; Performance; Phase; Positioning Attribute; Rib Fractures; Rod; Sales; Secondary to; Series; Small Business Innovation Research Grant; Spinal; Spine surgery; Surgeon; System; Techniques; Technology; Technology Transfer; Training; Universities; Vertebral column; bone quality; design; early onset; experience; instrumentation; manufacture; member; novel; programs; prospective; rib bone structure; sample fixation; scoliosis

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.

项目概要 脊柱畸形是一个具有挑战性的临床问题。曲率可以是横向（脊柱侧凸）、前向 方向（脊柱后凸）或两者（脊柱后凸）。早发性脊柱畸形 (EOSD) 是指开始出现脊柱畸形 10岁之前。手术矫正通常涉及将脊柱与杆和椎弓根螺钉对齐。 不幸的是，接受脊柱畸形手术的患者会经历高度的器械相关性 并发症发生率，会对结果产生负面影响并限制畸形矫正，特别是在以下情况下 涉及EOSD或成人后凸畸形。其中一些并发症包括近端固定丧失（椎弓根） 螺钉拔出）、杆断裂、近端交界后凸（PJK）和神经损伤。这个应用程序 提出了一种称为肋骨构造的新技术，用于矫正脊柱畸形，特别是在涉及脊柱畸形的情况下 EOSD 或严重的成人后凸畸形。肋骨结构不是用椎弓根螺钉将杆锚定到脊柱上 使用一系列钩子将近端固定移动到肋骨。这种方法是一种概念上的转变 脊柱畸形，即通过操作胸部来重新定位脊柱。肋结构允许 外科医生可以在矢状面、冠状面和轴向面的任意组合上操作胸部，从而更安全、 更有效、更通用的畸形矫正。肋骨结构的肋骨固定可以通过以下任一方式实现： 1) 标签外的椎板钩，其已经在商业上可用于将脊柱固定到椎板上，但也可以 用于肋骨，或 2) 肋骨钩，作为我们新型专利 R-FIX（肋骨固定系统）的一部分。当层流 在我们的初步临床使用中，钩子的表现优于椎弓根螺钉，这些已被 完全在标签外使用，并且没有专为该技术设计的市售手术系统。那里 曾出现扭转力下固定缺失、植入物突出以及偶尔出现肋骨脱落等问题 层状钩状骨折。 R-FIX系统，起源于一个生物工程实验室（申请人之一） 实验室）在克莱姆森大学，并由 Apex Orthopedic Technologies 进一步开发，旨在 解决这些问题。 SBIR 母奖项的目标有三个：1) 完成设计并 R-FIX 系统的制造，2) 通过肋骨结构证明肋骨固定的整体概念 获得基础科学数据来支持我们已经获得的临床数据，以及3）证明 与层流钩相比，R-FIX 肋骨钩具有卓越的性能。我们小组寻求加入 I-Corps 计划从行业领导者那里获取有关监管策略、知识产权策略、最终用户需求、 制造、销售。 I-Corp 计划期间制定的商业计划将用于 SBIR 将于 2023 年 9 月提交第二阶段。参与此 I-Corp 计划将带来以下额外好处： 提供一位有前途的年轻医学博士候选人和未来的骨科医生，以及一位积极向上的 即将成为神经外科医生，接受医疗设备开发转化方面的额外培训。每个 该团队的成员热衷于参与 I-Corp 计划。