X-ray Visualized Implanted Sensor for Prosthetic Joint Infection (X-VIS-PJI)

用于假体关节感染的 X 射线可视化植入传感器 (X-VIS-PJI)

基本信息

批准号：
10547368
负责人：
JEFFREY N ANKER
金额：
$ 30万
依托单位：
ARAVIS BIOTECH, LLC
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-07-15 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10547368
关键词：
Acidity Acidosis Animal Testing Animals Antibiotics Blood Businesses C-reactive protein Cadaver Calibration Carbomer-940 Catheters Cattle Chemicals Chronic Clinical Contracts Control Animal Debridement Development Devices Early Diagnosis Erythrocyte Sedimentation Rate Excision Failure Focal Infection Goals Health Care Costs Hip Prosthesis Hip region structure Histology Hour Human Hydrogels Implant In Situ In Vitro Incidence Infection Joint Prosthesis Joints Legal patent Life Liquid substance Location Measurement Measures Mechanics Methods Microbial Biofilms Modeling Monitor Morbidity - disease rate Neck Operative Surgical Procedures Optics Patients Performance Peritoneal Dialysis Persons Pharmaceutical Preparations Phase Physicians Physiological Positioning Attribute Property Prosthesis Protons Public Health Quality of life Rattus Reading Reporting Reproducibility Research Research Project Grants Resolution Risk Roentgen Rays Sampling Serum Services Sheep Small Business Innovation Research Grant Specimen Staphylococcus aureus infection Swelling Synovial Fluid Testing Thick Tissues Total Hip Replacement United States United States Agency for Healthcare Research and Quality Variant Work X-Ray Medical Imaging alpha-Defensins base clinically relevant commercialization cost design effective therapy feasibility testing follow-up hip replacement arthroplasty hydronium ion implantation implanted sensor improved in vivo inflammatory marker innovation joint infection mortality novel novel strategies prototype radiological imaging response sensor sensor technology sheep model standard of care

项目摘要

Abstract Our goal is to fabricate and validate a novel pH-indicating sensor which can attach to a hip prosthesis with integrated sensors that can detect and monitor hip infections using standard of care X-ray imaging. Hip replacement surgeries are performed on millions of people worldwide each year. In the United States alone, there were 450,000 total hip arthroplasties performed annually. Most of these surgeries are successful with no complications. However, infections are a leading cause of failure, with an incidence of about ~0.5-2% of total hip replacement surgeries. If detected early, these infections can be treated promptly with antibiotics and surgical debridement. However, mature biofilms usually require implant removal to treat the infection, followed by revision surgery with associated risks of morbidity, mortality, and large cost. Therefore, it’s important to detect post-surgery infections early and monitor the effect of therapies for effective treatment. We have developed novel pH-indicating sensors which can attach to a prosthesis, can measure local infection, and can be quantified using a standard x-ray. This Phase I SBIR will apply these pH-indicating sensors to the femoral- neck of a hip prosthesis and evaluate their utility in a sheep model. Our long term goal is to develop the first device that enables noninvasive local pH measurements using plain radiography. Further development could see the sensor integrated into the implant with further commercialization partnership. Our scientific premise is that acidosis in vivo can be measured noninvasively by conventional radiography using a pH-indicating device fabricated using hydrogels that respond mechanically to the presence of hydrogen ions. Preliminary studies show sufficient response rate, and pH sensitivity in the expected physiological pH range. We will refine the prototype in vitro and human cadaver models, and validate the sensor in vivo function using an animal hip model in sheep. The proposed research is significant because it develops a noninvasive method to detect, monitor, and study infection in situ with the ultimate potential for reducing morbidity, mortality and associated cost from implant infections.

抽象的我们的目标是制造并验证一种新型 pH 指示传感器，该传感器可以连接到髋关节假体上集成传感器可以使用标准护理髋关节 X 射线成像来检测和监测髋关节感染。仅在美国，每年就有数百万人接受置换手术。每年进行 450,000 例全髋关节置换术，其中大多数手术都是成功的。然而，感染是失败的主要原因，其发生率约占总数的 0.5-2%。如果及早发现髋关节置换手术，这些感染可以立即用抗生素和药物治疗。然而，成熟的生物膜通常需要去除植入物来治疗感染，然后进行手术清创。通过修复手术进行修复手术具有相关的发病率、死亡率和巨额费用的风险。及早发现手术后感染并监测治疗效果以进行有效治疗。开发了新型 pH 指示传感器，可以连接到假体上，可以测量局部感染，并且可以使用标准 X 射线进行量化第一阶段 SBIR 将把这些 pH 指示传感器应用到股骨上。我们的长期目标是开发第一个髋关节假体颈部并评估其在绵羊模型中的实用性。可以进一步开发使用普通放射线照相技术进行无创局部 pH 测量的设备。通过进一步的商业化合作，将传感器集成到植入物中是我们的科学前提。体内酸中毒可以通过使用 pH 指示装置的传统放射线照相技术进行无创测量初步研究是使用对氢离子的存在做出机械反应的水凝胶制成的。在预期的生理 pH 范围内表现出足够的响应率和 pH 敏感性。制作体外和人体尸体模型原型，并使用动物髋关节验证传感器的体内功能所提出的研究具有重要意义，因为它开发了一种非侵入性方法来检测，监测和研究原位感染，最终有可能降低发病率、死亡率和相关疾病种植体感染造成的费用。