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Design Considerations to Facilitate Clinical Radiological Evaluation of Implantable Biomedical Structures
ACS Biomaterials Science & Engineering ( IF 5.4 ) Pub Date : 2021-01-13 , DOI: 10.1021/acsbiomaterials.0c01439 Kendell M Pawelec 1 , Shatadru Chakravarty 1 , Jeremy M L Hix 1 , Karen L Perry 2 , Lodewijk van Holsbeeck 1 , Ryan Fajardo 1 , Erik M Shapiro 1
ACS Biomaterials Science & Engineering ( IF 5.4 ) Pub Date : 2021-01-13 , DOI: 10.1021/acsbiomaterials.0c01439 Kendell M Pawelec 1 , Shatadru Chakravarty 1 , Jeremy M L Hix 1 , Karen L Perry 2 , Lodewijk van Holsbeeck 1 , Ryan Fajardo 1 , Erik M Shapiro 1
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Clinical effectiveness of implantable medical devices would be improved with in situ monitoring to ensure device positioning, determine subsequent damage, measure biodegradation, and follow healing. While standard clinical imaging protocols are appropriate for diagnosing disease and injury, these protocols have not been vetted for imaging devices. This study investigated how radiologists use clinical imaging to detect the location and integrity of implanted devices and whether embedding nanoparticle contrast agents into devices can improve assessment. To mimic the variety of devices available, phantoms from hydrophobic polymer films and hydrophilic gels were constructed, with and without computed tomography (CT)-visible TaOx and magnetic resonance imaging (MRI)-visible Fe3O4 nanoparticles. Some phantoms were purposely damaged by nick or transection. Phantoms were implanted in vitro into tissue and imaged with clinical CT, MRI, and ultrasound. In a blinded study, radiologists independently evaluated whether phantoms were present, assessed the type, and diagnosed whether phantoms were damaged or intact. Radiologists identified the location of phantoms 80% of the time. However, without incorporated nanoparticles, radiologists correctly assessed damage in only 54% of cases. With an incorporated imaging agent, the percentage jumped to 86%. The imaging technique which was most useful to radiologists varied with the properties of phantoms. With benefits and drawbacks to all three imaging modalities, future implanted devices should be engineered for visibility in the modality which best fits the treated tissue, the implanted device’s physical location, and the type of required information. Imaging protocols should also be tailored to best exploit the properties of the imaging agents.
中文翻译：
促进可植入生物医学结构的临床放射学评估的设计考虑因素
通过原位监测，可提高植入式医疗器械的临床效果，以确保器械定位、确定后续损伤、测量生物降解并跟踪愈合情况。虽然标准临床成像协议适用于诊断疾病和损伤，但这些协议尚未经过成像设备的审查。这项研究调查了放射科医生如何使用临床成像来检测植入设备的位置和完整性，以及将纳米颗粒造影剂嵌入设备中是否可以改善评估。为了模拟各种可用的设备，构建了疏水性聚合物薄膜和亲水性凝胶的模型，有或没有计算机断层扫描（CT）可见的TaO x和磁共振成像（MRI）可见的Fe 3 O 4纳米颗粒。一些模型被刻痕或横切故意损坏。将模型在体外植入组织中，并通过临床 CT、MRI 和超声进行成像。在一项盲法研究中，放射科医生独立评估体模是否存在、评估类型并诊断体模是否受损或完好。80% 的情况下，放射科医生都能识别出体模的位置。然而，如果没有掺入纳米颗粒，放射科医生只有 54% 的病例能够正确评估损伤。加入显像剂后，该百分比跃升至 86%。对放射科医生最有用的成像技术因体模的特性而异。考虑到所有三种成像方式的优点和缺点，未来的植入设备应该设计成最适合治疗组织、植入设备的物理位置和所需信息类型的方式的可见性。还应该定制成像方案以最好地利用成像剂的特性。
更新日期：2021-02-08
中文翻译：
促进可植入生物医学结构的临床放射学评估的设计考虑因素
通过原位监测，可提高植入式医疗器械的临床效果，以确保器械定位、确定后续损伤、测量生物降解并跟踪愈合情况。虽然标准临床成像协议适用于诊断疾病和损伤，但这些协议尚未经过成像设备的审查。这项研究调查了放射科医生如何使用临床成像来检测植入设备的位置和完整性，以及将纳米颗粒造影剂嵌入设备中是否可以改善评估。为了模拟各种可用的设备，构建了疏水性聚合物薄膜和亲水性凝胶的模型，有或没有计算机断层扫描（CT）可见的TaO x和磁共振成像（MRI）可见的Fe 3 O 4纳米颗粒。一些模型被刻痕或横切故意损坏。将模型在体外植入组织中，并通过临床 CT、MRI 和超声进行成像。在一项盲法研究中，放射科医生独立评估体模是否存在、评估类型并诊断体模是否受损或完好。80% 的情况下，放射科医生都能识别出体模的位置。然而，如果没有掺入纳米颗粒，放射科医生只有 54% 的病例能够正确评估损伤。加入显像剂后，该百分比跃升至 86%。对放射科医生最有用的成像技术因体模的特性而异。考虑到所有三种成像方式的优点和缺点，未来的植入设备应该设计成最适合治疗组织、植入设备的物理位置和所需信息类型的方式的可见性。还应该定制成像方案以最好地利用成像剂的特性。
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