A Smart, Fully Subcutaneous Distraction System to Improve Outcomes in Patients with Congenital or Acquired Craniofacial Differences

智能、全皮下牵引系统可改善先天性或后天性颅面差异患者的治疗效果

基本信息

批准号：
10696721
负责人：
Jessica DesNoyer
金额：
$ 89.25万
依托单位：
OSTIIO LLC
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-14 至 2025-09-13
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10696721
关键词：
Address Adopted Adoption Affect Analgesics Anesthesia procedures Animal Model Animals Autopsy Bilateral Biological Blinded Blood Transfusion Bone Growth Bone Regeneration Bone structure Breathing Buffers Caregivers Caring Cephalic Cicatrix Clinic Clinical Communication Coupling Craniofacial Abnormalities Defect Development Device Designs Devices Distraction Osteogenesis Ensure Environment Evaluation Exhibits Exposure to Family suidae Freezing Generations Growth Hearing Histologic Home Housing Immersion Impairment Implant Infection Length of Stay Liquid substance Magnetism Mandible Manuals Mastication Measures Miniature Swine Modality Monitor Neurologic Newborn Infant Operative Surgical Procedures Osteotomy Outcome Output Pain Particulate Patient risk Patient-Focused Outcomes Patients Phase Physicians Process Protocols documentation Radiation exposure Risk Safety Saline Sampling Shapes Site Skeleton Skin Specific qualifier value Specimen Speech Surgeon System Systems Integration Techniques Technology Testing Therapeutic Time Tissues Torque Training Treatment Failure Treatment Protocols Validation Vision Visual biomaterial compatibility bone craniofacial craniomaxillofacial cranium design distraction effectiveness testing experience functional restoration implantation improved improved outcome in vivo manufacture non-compliance novel strategies operation patient population performance tests prevent prototype reconstruction remote monitoring seal skeletal stem subcutaneous success wireless communication

项目摘要

SUMMARY / ABSTRACT Each year, ~200,000 newborns worldwide, 80-85% of whom require surgical intervention, are afflicted with congenital conditions that cause impaired growth of the skull or mandible, leading to abnormalities that affect breathing, hearing, speech, visual function, neurologic development, and mastication. Unfortunately, current surgical treatments, including endoscopic surgery, open reconstruction, and distraction osteogenesis (DO), suffer inherent drawbacks, impacting outcomes. A better solution is needed for this vulnerable patient population. DO is a widely recognized treatment modality that harnesses the body’s natural ability to regenerate bone in order to correct skeletal deficiencies and defects. While still emerging for craniomaxillofacial (CMF) applications, surgeons have shown the utility of DO for restoring functional discrepancies in patients with craniofacial differences. The technique of DO involves surgical placement of one or more distractors, which are devices used to slowly separate two opposing bony fragments at an osteotomy site, to gradually lengthen and reshape the affected bone and stimulate new bone growth. However, DO is not without shortcomings. First, all current distractors have an external component for manual expansion. The external component significantly increases patient risk for complications such as infection (35%), device dislodgement (3.0%), increased analgesic use, and scarring (15.6%). Second, since the burdensome responsibility for manual expansion lies with the caregiver, treatment noncompliance (4.7%) is a serious issue, introducing vulnerabilities ranging from inconsistent device expansion to complete treatment failure. Therefore, DO necessitates extensive physician clinic time and patient radiation exposure to monitor therapeutic progress and thus has not been widely adopted in the CMF skeleton despite recognition of potential advantages over endoscopic surgery (narrower indication for use) and open reconstruction (more invasive, longer anesthesia time, higher blood transfusion rate, longer hospital stay). The Ostiio distraction system addresses many of the issues associated with DO treatment as the first fully subcutaneous, programmable DO system for the CMF skeleton. At a high level, the Ostiio distraction system leverages magnetic coupling to transfer torque from the hand-held driver (HHD) to the implant, thereby expanding the implant in a contactless fashion. This novel approach will markedly reduce infection, scarring, and manipulation noncompliance. In addition, because the design uniquely permits wireless communication between the implant and HHD, it will enable physicians to better control and monitor treatment progress. This Phase II proposal aims to a) achieve design freeze of the integrated Ostiio distraction system, incorporating design improvements to ensure device biocompatibility and functionality throughout active distraction, and b) demonstrate the system can be used safely and effectively to perform a complete distraction protocol in vivo in standard animal model. Successful demonstration of this outcome will satisfy key validation performance testing requirements for FDA submission and 510(k) clearance and open a path to widespread clinical adoption.

摘要/摘要每年，全球约有 200,000 名新生儿，其中 80-85% 需要手术干预先天性疾病会导致颅骨或下颌骨生长受损，从而导致影响的异常不幸的是，呼吸、听力、言语、视觉功能、神经发育和咀嚼功能。手术治疗，包括内窥镜手术、开放重建和牵引成骨（DO），存在固有的缺陷，影响了这一弱势患者群体的治疗效果。 DO 是一种广泛认可的治疗方式，它利用人体自然的骨骼再生能力为了纠正骨骼缺陷和缺陷，虽然在颅颌面（CMF）应用中仍然出现，外科医生已经展示了 DO 在恢复颅面部患者功能差异方面的实用性 DO 技术涉及通过手术放置一个或多个牵引器，这些牵引器是一种装置。用于在截骨部位缓慢分离两个相对的骨碎片，以逐渐拉长和重塑然而，DO 并非没有缺点。牵引器有一个外部组件，用于手动扩展外部组件显着增加。患者出现并发症的风险，例如感染 (35%)、装置移位 (3.0%)、镇痛药使用增加以及其次，由于手动扩张的繁重责任在于护理人员，治疗不合规（4.7％）是一个严重的问题，引入了设备不一致等漏洞因此，DO 需要大量的医生临床时间和患者。辐射暴露来监测治疗进展，因此尚未在 CMF 骨骼中广泛采用认识到相对于内窥镜手术（使用范围更窄）和开放手术的潜在优势重建（更具侵入性、更长的麻醉时间、更高的输血率、更长的住院时间）。 Ostiio 分散注意力系统解决了与 DO 治疗相关的许多问题，这是第一个完全用于 CMF 骨骼的皮下可编程 DO 系统在高水平上，Ostiio 牵引系统。利用磁耦合将扭矩从手持式驱动器 (HHD) 传递到种植体，从而这种以非接触方式扩展植入物的新颖方法将显着减少感染、疤痕和疤痕。此外，由于独特的设计允许之间进行无线通信。植入物和 HHD 将使医生能够更好地控制和监测治疗进展。该第二阶段提案旨在 a) 实现集成 Ostiio 分心系统的设计冻结，包括设计改进，以确保设备在主动分散注意力过程中的生物相容性和功能，以及 b) 证明该系统可以安全有效地在体内执行完整的分心协议标准动物模型的成功证明将满足关键的验证性能测试。 FDA 提交和 510(k) 批准的要求，并为广泛的临床采用开辟了道路。