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

• 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
• 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

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，全世界约有20万新生儿患有此病，其中80%-85%需要手术治疗 导致头骨或下颌骨发育受损的先天性疾病，导致影响 呼吸、听力、言语、视觉功能、神经发育和咀嚼。不幸的是，目前 外科治疗，包括内窥镜手术、开放重建和牵引成骨(DO)， 遭受固有的缺陷，影响结果。对于这一脆弱的患者群体，需要一个更好的解决方案。 DO是一种被广泛认可的治疗方式，它利用身体的自然能力在 以纠正骨骼缺陷和缺陷。虽然仍在颅颌面(CMF)应用中出现， 外科医生已经证明了DO在修复颅面部疾病患者功能差异方面的效用 不同之处。DO的技术包括手术放置一个或多个牵引器，这些牵引器是设备 用来在截骨部位慢慢地分开两个相对的骨头碎片，以逐渐延长和重塑 并刺激新的骨骼生长。然而，做并不是没有缺点的。首先，都是最新的 牵引器有一个外部组件，可用于手动扩展。外部组件显著增加 患者出现并发症的风险，如感染(35%)、装置移位(3.0%)、止痛剂使用量增加以及 瘢痕形成(15.6%)。其次，由于手动扩展的繁重责任在于照顾者， 治疗不依从性(4.7%)是一个严重的问题，导致设备不一致等各种漏洞 扩张以完成治疗失败。因此，做DO需要大量的医生临床时间和患者 放射照射监测治疗进展，因此在CMF骨骼中尚未被广泛采用 尽管人们认识到内窥镜手术(使用适应症较窄)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分心系统解决了与DO治疗相关的许多问题，作为第一个完全 皮下可编程的CMF骨骼DO系统。在更高的水平上，Ostiio分心系统 利用磁耦合将扭矩从手持驱动器(HHD)传递到植入物，从而 以非接触式方式扩展植入物。这一新方法将显著减少感染、疤痕和 操纵不合规。此外，由于该设计独特地允许在 植入物和HHD，它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分流系统的设计冻结，包括 改进设计，以确保设备在整个主动分心过程中的生物兼容性和功能，以及b) 证明该系统可以安全和有效地用于在体内执行完整的分心方案 标准动物模型。成功演示此结果将满足关键验证性能测试 FDA提交和510(K)批准的要求，并为广泛的临床采用开辟了一条道路。