Novel contrast agent tool for musculoskeletal injection procedures

摘要 使用超声引导的关节内和关节外结构的注射治疗是主要的治疗方法之一。 肌肉骨骼（MSK）疼痛的医疗治疗，然而，这些注射是无法获得的， 肥胖或无法长时间等待专科中心的患者。正确的针头位置和 注射物的可视化对于使整形外科医生和运动医学医生能够执行这些操作是重要的 注射在肥胖患者在美国，以及使培训和建立信心，一般 在初级保健办公室进行注射，从而改善获得。因此，这一目标 第1阶段项目是设计和开发用于输送微气泡的MSK ORBIS造影剂 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 需要MSK注射程序。如果成功的话，其部分好处将是改善对MSK的访问 注射到肥胖患者和通过全科医生，可以执行注射在初级保健 诊所其他好处可能包括更准确的注射，因此， 患者，执行注射所需的资源更少，并且对注射过程本身更有信心。 ORBIS装置连接到药物填充注射器的末端，并立即产生药物的分散。 注射过程中的微气泡。在初步尸体测试和台架测试中， 显示出在超声下产生回声并迅速消散的微泡， 提供者在错过关节内注射的情况下重新定位针头。本提案的具体目标 如下：1）开发和测试MSK ORBIS设备，以满足设计标准，包括一致性 微泡浓度、最佳回声反射性和可视化、消散，以及与不同液体一起使用 在超声引导下进行髋关节和肩关节注射的粘度; 2）验证 通过将实验室数据与一系列中期尸体研究相关联进行ORBIS器械设计，以及3） 在一项旨在评价ORBIS的针头放置和注射准确性的研究中验证ORBIS 在尸体的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，以提高从业人员的注射准确性。

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.