Magnetic Mini Mover Device for the Treatment of Pectus Excavatum

项目摘要 漏斗胸(胸部凹陷)的修复术目前需要进行一次大的手术修复。 伴随着术后3-7天的住院和门诊处方治疗 止痛药。我们已经创造了利用磁力的磁性微动系统 以重塑病人异常的胸部。植入的磁铁在30-60分钟内放置 一分钟的门诊程序和病人通常在当天非处方药回家 止痛药。磁性微动系统是治疗胸腔积液最有效的方法 青春期前患者的畸形，但在胸壁僵硬的较大青少年中效果较差，因此 在第二个试验中，我们只治疗青春期前的患者。该装置已经在25名患者身上进行了试验 但将植入物固定在胸骨上的方法已经被证明 这是个问题。 磁性MIMI MOVER装置目前由一个钕铁硼圆盘磁铁组成， (直径1.5厘米x 3/16英寸厚)和封装在低轮廓中的铁磁聚焦板 钛合金外壳。它被固定在胸骨上，使用编织的钛缆和钛合金 背板。电缆是钛合金(Ti-6Al-4V ELI)，由7股钢丝缠绕在一起 然后将每根0.0065英寸的7根电缆缠绕在一起，形成0.05940英寸的编织电缆 15.875英寸长。这种配置是为商业上可用的整形外科开发的 钛金属电缆。外部定制支架内装有另一块稀土磁铁，可以 使用内置于矫形器支架中的塑料外壳进行调整。磁铁的调整 距离将在24-36个月内慢慢拉出胸部，过程类似于 正畸学。 该设备获得了专利(美国8043290)，我们正在申请对新设计的修改，因为 以及外部支撑。它还获得了人道主义用途指定(08- 0200)来自FDA。我们已经完成了我们的第一个临床试验，并正在进行第二个多 中心由FDA孤儿产品办公室资助。在这两个试验中，我们都有一个 设计内部磁铁很困难，特别是将它连接到胸骨上，并开发出一种 对称和不对称胸骨的通用形状。然而，胸腔的修复 由于将设备封装在胸骨上，手术成功。 我们正在申请资金，以修改植入磁铁外壳的设计和手段 把它固定在胸骨上。这将是第三次，也可能是之前的最后一次设计迭代 商业化。在最后一次试验中，我们认识到了将 患者的呼吸作为一种测试，以确定植入物的强度和生存能力。这项研究将 评估和创建： 1.量化患者呼吸对新设备设计的影响的方法 2.种植体上的锁定机构最好能保持种植体的不动 胸骨保持不动 3.一种不会损伤胸骨上的骨和软骨的机制， 4.一种最适合于胸骨上最明显的骨病的机械装置 在两年的审判过程中。

Project Summary Repair of pectus excavatum (sunken Chest) currently involves a major surgical repair accompanied by a 3-7 day post-operative hospital stay and outpatient treatment with prescription pain medication. We have created the Magnetic Mini-Mover System which utilizes magnetic force to reconfigure the patient's abnormal chest. The implanted magnet is placed during a 30-60 minute outpatient procedure and the patient usually goes home the same day on over-the-counter pain medication. The Magnetic Mini Mover System was most effective in treating the Pectus deformity in pre-pubertal patients but less effective in older teens with more rigid chest walls, so in the second trial we treated only pre pubertal patients. The device has been trialed in 25 patients where the concept works, but the means to anchor the implant to the sternum has proven problematic. The Magnetic Mimi Mover Device, currently consists of a neodymium iron boron disc magnet, (1.5 cm diameter x 3/16 in. thick) and a ferromagnetic focusing plate encased in a low-profile titanium shell. It is held in place on the sternum using woven titanium cables and a titanium backing plate. The cable is titanium alloy (Ti-6Al-4V ELI) of 7 wire strands wrapped into a cable then 7 cables each 0.0065” are wrapped together to given a woven cable of 0.05940” and 15.875” in length. This configuration was developed for commercially available orthopedic titanium cables. The external custom brace houses another rare- earth magnet that can be adjusted using a plastic housing built into the orthotic brace. Adjustments in the magnets distances will slowly pull the chest out over 24-36 months in a process similar to that used in orthodontics. The device is patented (US 8043290) and we are filing for modifications to the new design as well as the external brace. It has also and has obtained a Humanitarian Use Designation (08- 0200) from the FDA. We have completed our 1st clinical trial and in the midst of a 2nd multi- centered funded by the Office of Orphan Products at the FDA. In both trials we have had a difficulty designing the internal magnet, specifically attaching it to the sternum and developing a universal shape for both symmetrical and asymmetrical sternums. However the chest repairs were successful due to the encapsulation of the device on sternum. We are requesting funds to modify the design of the implanted magnet housing and the means of attaching it to the sternum. This will be the third and potentially the last design iteration before commercialization. During the last trial we learned the importance of including the effects of patient respirations as a test to determine the strength and viability of the implant. This study will evaluate and create: 1. A means to quantify the effects of patient respirations on the design of the new device 2. A locking mechanism on the implant that will best remain immovableof implant will best remain immovable on the sternum 3. A mechanism that will not injure the bone and cartilage on the sternum, 4. A mechanism fit best onto the bone disorder most noticeable on the sternum during the course of the two year trial.