Novel contrast agent tool for musculoskeletal injection procedures

摘要 超声引导下的关节内和关节外结构注射疗法是主要的治疗方法之一。 可用于肌肉骨骼(MSK)疼痛的药物治疗，然而，这些注射是无法获得的 肥胖或无法等待很长时间才能去专科中心就诊的患者。正确的针头位置和 注射物的可视化对于使骨科医生和运动医学医生能够执行这些操作很重要 在美国，为肥胖患者注射疫苗，并使培训和建立信心成为可能 医生将在其初级保健办公室进行注射，从而改善获得注射的机会。因此，这一目标是 第一阶段项目是设计和开发MSK ORBIS造影剂，用于输送空气的微气泡 混合在治疗鸡尾酒中，用作提高准确性和降低训练水平的工具 MSK注射程序所需的。如果成功，部分好处将是改善了对MSK的访问 对肥胖患者进行注射，并通过能够在初级保健中进行注射的全科医生进行 诊所。其他好处可能包括更准确的注射，因此， 患者，进行注射所需的资源更少，对注射过程本身更有信心。 ORBIS设备连接到充满药物的注射器的末端，并瞬间产生分散的 注射过程中出现微泡。在初步身体测试和台式测试中，ORBIS设备是 显示产生在超声波下回声的微泡，并迅速消散，使 在遗漏关节内注射的情况下，请提供者重新定位针头。这项建议的具体目的 具体如下：1)开发和测试MSK ORBIS设备以满足设计标准，包括一致 微泡浓度、最佳回声和可视化、消散和与不同流体一起使用 超声引导下髋关节和肩关节注射的粘度；2)验证 通过将台面数据与一系列临时身体研究相关联的Orbis装置设计和3) 在一项旨在评估ORBIS的针头放置和注射准确性的研究中验证ORBIS 在身体肩关节和髋关节中使用具有不同经验水平的临床医生。通过这些目标， ORBIS的临床应用将得到优化和验证，以提高从业者的注射准确性。

Abstract Injection therapy for intra and extra-articular structures using ultrasound guidance is one of the principal medical treatments available for musculoskeletal (MSK) pain, however, these injections are inaccessible to patients who are obese or unable to wait a long time to visit a specialty center. Correct needle placement and visualization of the injectate is important to enable orthopedists and sports medicine doctors to perform these injections in obese patients under US, as well as to enable training and build confidence in general practitioners to conduct injections in their primary care offices, thus improving access. As such, the goal of this Phase 1 project is to design and develop the MSK ORBIS Contrast Device for delivery of microbubbles of air mixed in therapeutic cocktails for use as a tool to increase the accuracy and reduce the level of training needed for MSK injection procedures. If successful, the benefit, in part, would be improved access to MSK injections to obese patients and through general practitioners that can perform the injections in a primary care clinic. Other benefits potentially include more accurate injections and as such, less pain experienced by patients, less resources required to perform an injection, and more confidence in the injection procedure itself. The ORBIS device attaches to the end of a drug-filled syringe and instantaneously creates a dispersion of microbubbles during injection. In preliminary cadaver testing and benchtop testing, the ORBIS device was shown to produce microbubbles that are echogenic under ultrasound and dissipate quickly, allowing the provider to reposition the needle in cases of missed intra-articular injections. The specific aims of this proposal are as follows: 1) develop and test the MSK ORBIS device to meet design criteria including consistent microbubble concentration, optimal echogenicity and visualization, dissipation, and use with fluids of different viscosities for hip and shoulder joint injections under ultrasound guidance; 2) verify the clinical utility of the ORBIS device design through relating the benchtop data with a series of interim cadaveric studies and 3) validate the ORBIS in a study designed to evaluate the needle placement and injection accuracy of the ORBIS in cadaver shoulder and hip joints utilizing clinicians with varied experience levels. Through these aims, the clinical utility of the ORBIS will be optimized and validated for improving injection accuracy for practitioners.