The X-VISUAL (X-ray Visualized Indicator for Screw-strain Under Applied Load)

X-VISUAL（施加负载下螺钉应变的 X 射线可视化指示器）

• 批准号: 10822470
• 负责人: John David DesJardins
• 金额: $ 30万
• 依托单位: ARAVIS BIOTECH, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-25 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10822470
• 关键词: Address; Anatomy; Body Weight; Bone callus; Cadaver; Cannulations; Caring; Clinical; Collaborations; Communication; Computer Models; Day Surgery; Device or Instrument Development; Devices; Excision; Failure; Fatigue; Feedback; Femur; Finite Element Analysis; Fracture; Fracture Fixation; Geometry; Growth; Health care facility; Hip Fractures; Hip region structure; Hospital Mortality; Human; Image; Image Analysis; Implant; Industry; Interobserver Variability; Intertrochanteric Fractures; Intervention; Intramedullary Nailing; Lead; Legal patent; Length; Life Expectancy; Location; Measurement; Measures; Mechanics; Medical Device Designs; Methodology; Methods; Modeling; Morbidity - disease rate; Morphology; Motion; Nail plate; Operative Surgical Procedures; Optics; Orthopedic Surgery; Orthopedics; Osteoporosis; Outcome; Pathology; Patient Readmission; Patients; Pelvis; Periodicity; Phase; Physicians; Positioning Attribute; Postoperative Period; Procedures; Public Health; Quality of life; Radiology Specialty; Recording of previous events; Research; Research Project Grants; Risk; Roentgen Rays; Sales; Second Look Surgery; Sheep; Slide; Small Business Innovation Research Grant; Specimen; Surveys; System; Techniques; Testing; Time; Traction; Trochanters; Visual; Weight; Weight-Bearing state; Work; X ray visualization; X-Ray Medical Imaging; arm; biomechanical test; bone; bone fracture repair; bone healing; clinical predictors; clinical translation; clinically relevant; comorbidity; cost; design; fracture risk; healing; human old age (65+); human tissue; imaging modality; improved; individual patient; individualized medicine; innovation; manufacture; mechanical device; mortality; novel; operation; patient mobility; patient population; physical therapist; prevent; prototype; radiological imaging; response; sample fixation; sensor; simulation; standard of care; time use

ABSTRACT We are developing and sensor, the X-VISUAL (X-ray Visualized Indicator for Screw bending Under Applied Load), to track fracture healing in canulated screws used to treat hip fractures. Hip fractures are a major public health concern with high in-hospital mortality rate. Approximately 330,000 hip fixation procedures are performed annually in the US. The average hip fixation hardware failure rate is around 5%, but increases to over 20% in patients with comorbidities such as osteoporosis, unstable fractures and poor initial fracture reduction. When healing is delayed, the screw, other hardware, and bone can fatigue and fail, requiring costly revision surgery with significant risk of morbidity and mortality for these frail patients. For example, the 1-year all-cause mortality rate for patients readmitted within 30 days of surgery is 56%, compared to 19% for those not readmitted. Screws only bend and cutout when they are loaded, and this risk disappears as a fracture callus heals and carries the load. Thus, measuring screw bending under standing load is an ideal way to assess fracture healing and risk failure. This improves communications with the patient and care team, enabling normally healing patients and physical therapists to feel more comfortable with activity, while detecting and avoiding pathologies for slowly healing patients. Innovatively, the X-VISUAL is the first sensor that can detect screw bending (and associated load on the screw), a measurement that is hard to perform in other ways because of the confined geometry. The patent protected device is designed to load into a screw after guidewire removal, and is read using plain radiography which is ubiquitously available in healthcare facilities but is usually insensitive to mechanical strain and usually detects pathologies when they have progressed so far that non-surgical interventions often don’t work. Using previous designs we demonstrated proof of concept for measuring screw bending with X-rays in Sawbones specimens, FEA models, cadaveric specimens, and tracked healing in a sheep. However, the old designs were cumbersome to insert and read, thus this Phase I proposal designs an elegant addon with a gain mechanism and readout on indicator along the pin. We will develop and test the design in FEA computational models, sawbones, and cadaveric specimens. The clinical, industry, and academic partners assembled for this work have a strong history of collaboration in orthopaedic device development and testing. They bring together expertise in measurement systems, mechanical testing, medical device design and orthopaedic surgery. The research is relevant to public health because, it provides a non-invasive means of assessing biomechanical reduction and postop fracture healing to avoid costly and risky revisions.

抽象的 我们正在开发和传感器，即X-Visual（X射线可视化指示器，用于施加的螺钉弯曲的指示器 负载），以跟踪用于治疗髋部骨折的管治性的骨折愈合。髋部骨折是主要的公众 健康关注的院内死亡率高。大约330,000个髋关节固定程序是 每年在美国执行。平均髋关节固定硬件故障率约为5％，但增加到 合并症患者（例如骨质疏松症，不稳定骨折和初始骨折较差）的患者超过20％ 减少。延迟愈合时，螺钉，其他硬件和骨头会疲劳和失败，需要昂贵 这些脆弱的患者的重大风险和死亡率的重大风险。例如，1年 手术后30天内入学的患者的全因死亡率为56％，而19％的死亡率为19％ 未重新读取。螺钉加载时仅弯曲和切口，这种风险随着骨折而消失 愈伤组织可以治愈并承担负载。那就是测量螺钉弯曲理解站立载荷是一种理想的方式 评估断裂愈合和风险失败。这改善了与患者和护理团队的沟通， 使通常可以治愈患者和物理治疗师对活动感到更舒适，而 检测并避免缓慢治愈患者的病理。创新，X-Visual是第一个传感器 可以检测到螺钉弯曲（以及螺钉上相关的负载），这是一个难以执行的测量 由于几何形状，其他方式。专利保护的设备设计为装载到螺钉中 拆除导线后，并使用普通射线照相术在医疗保健中无处不在 设施，但通常对机械应变不敏感，通常会发现病理 到目前为止，非手术干预措施通常不起作用。使用以前的设计我们证明了 用X射线测量锯骨标本，FEA型号，尸体的X射线弯曲的概念证明 标本，并在绵羊中追踪愈合。但是，旧设计很麻烦，可以插入和阅读， 该阶段我提出了一个具有增益机制的优雅插件，并在指示器上读数 销。我们将在FEA计算模型，锯骨和尸体上开发和测试设计 标本。为这项工作组装的临床，行业和学术伙伴有悠久的历史 骨科设备开发和测试的协作。他们汇集了测量方面的专业知识 系统，机械测试，医疗设备设计和骨科手术。该研究与 公共卫生是因为它提供了评估生物力学减少和邮政的无创含义 断裂愈合以避免昂贵和冒险的修订。