Magnetic Mini Mover Device for the Treatment of Pectus Excavatum

磁力微型移动器治疗漏斗胸

• 批准号: 9202058
• 负责人: MICHAEL R HARRISON
• 金额: $ 82.53万
• 依托单位: MAGNETS-IN-ME, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-28 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9202058
• 关键词: Affect; Age; Alloys; Analgesics; Back; Biomechanics; Bone Diseases; Bone remodeling; Boron; Breathing; Caliber; Cartilage; Chest; Chest wall structure; Clinical Trials; Congenital funnel chest; Custom; Deformity; Devices; Evaluation; Exhalation; Face; Funding; Goals; Home environment; Hospitals; Hour; Housing; Implant; Institutional Review Boards; Iron; Learning; Legal patent; Length; Length of Stay; Libraries; Magnetism; Measurement; Mechanics; Modification; Monitor; Movement; Neodymium; Operative Surgical Procedures; Orphan; Orthodontics; Orthopedics; Outcome; Outpatients; Patients; Phase; Play; Positioning Attribute; Postoperative Period; Procedures; Process; Protocols documentation; Research Personnel; Research Project Grants; Respiration; Role; Series; Shapes; Small Business Innovation Research Grant; Sterilization; Sternum; Stress; System; Teenagers; Testing; Thick; Titania; Titanium; Work; X-Ray Computed Tomography; base; bone; commercialization; cost; design; experience; improved; injured; operation; orthotics; repaired; respiratory; three-dimensional modeling; tool

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.

项目摘要 修复漏斗胸（凹陷的胸部）目前涉及一个大的手术修复 伴随3-7天的术后住院和门诊处方治疗 止痛药我们创造了利用磁力的磁性微型移动器系统 重新配置病人异常的胸腔植入的磁铁放置在30-60 分钟门诊程序和病人通常回家的同一天在柜台上 止痛药磁性微型移动系统是治疗胸部最有效的方法 畸形的青春期前患者，但在年龄较大的青少年更僵硬的胸壁， 在第二个试验中，我们只治疗青春期前的患者。该装置已在25名患者中试用 但将植入物锚在胸骨上的方法已经证明 有问题 磁性咪咪移动装置，目前包括一个钕铁硼圆盘磁铁， (1.5 cm直径x 3/16 in.厚）和一个铁磁聚焦板， 钛合金外壳使用编织的钛缆和钛合金支架将其固定在胸骨上。 垫板电缆为钛合金（Ti-6Al-4V ELI），由7股钢丝缠绕而成， 然后将7根电缆（每根0.0065”）缠绕在一起，得到0.05940”的编织电缆， 15.875英寸长。这种配置是为市售骨科产品开发的 钛电缆外部定制支架容纳另一个稀土磁铁， 使用内置于矫正支架中的塑料外壳进行调节。磁铁的调整 距离将在24-36个月内缓慢地将胸部拉出，其过程类似于 南极洲。 该设备已获得专利（US 8043290），我们正在申请对新设计的修改， 以及外部支架。它还获得了人道主义用途指定（08- 0200）从FDA。我们已经完成了我们的第一个临床试验，并在第二个多- 由FDA孤儿产品办公室资助。在这两次试验中， 难以设计内部磁铁，特别是将其固定在胸骨上并开发一种 对称和不对称胸骨的通用形状。但是胸部的修复 由于将器械封装在胸骨上，因此获得了成功。 我们正在申请资金，以修改植入式磁体外壳的设计和方法， 把它固定在胸骨上这将是第三次，也可能是最后一次设计迭代， 商业化在最后一次试验中，我们了解到包括以下影响的重要性： 患者呼吸作为测试，以确定植入物的强度和可行性。本研究将 评估和创建： 1.量化患者呼吸对新器械设计影响的方法 2.植入物上最好保持不动的锁定机制 在胸骨上保持不动 3.一种不会伤害胸骨上的骨头和软骨的机制， 4.一种机制最适合在胸骨上最明显的骨骼疾病， 在两年的审判中。