Novel contrast agent tool for musculoskeletal injection procedures

用于肌肉骨骼注射程序的新型造影剂工具

• 批准号: 10483672
• 负责人: Morgan Elizabeth Evans
• 金额: $ 28.2万
• 依托单位: AGITATED SOLUTIONS INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10483672
• 关键词: Absence of pain sensation; Adoption; Adrenal Cortex Hormones; Air; Analgesics; Anatomy; Anesthesia procedures; Anesthetics; Area; Cadaver; Caring; Client satisfaction; Clinic; Clinical; Communities; Contrast Media; Data; Device Designs; Devices; Diagnosis; Doctor of Medicine; Educational Status; Ensure; Equipment; Evaluation; Exercise; Feedback; Fluoroscopy; General Practices; General Practitioners; Goals; Gold; Grant; Hip Joint; Human Resources; Hyaluronic Acid; Improve Access; Inflammation; Injection of therapeutic agent; Injections; Intra-Articular Injections; Ionizing radiation; Ireland; Joint structure of shoulder region; Joints; Lead; Light; Liquid substance; Location; Lubricants; Medical; Microbubbles; Morbidity - disease rate; Muscle; Musculoskeletal; Musculoskeletal Pain; Needles; Nerve; Obesity; Orthopedics; Pain; Palpation; Patients; Performance; Pharmaceutical Preparations; Phase; Physical Medicine; Physicians; Primary Health Care; Procedures; Provider; Quality of life; Rehabilitation therapy; Research Design; Resources; Respondent; Rheumatology; Sacroiliac joint structure; Safety; Schedule; Series; Service delivery model; Site; Specialist; Sports Medicine; Steroids; Stream; Stretching; Structure; Surveys; Syringes; Techniques; Tendon structure; Testing; Therapeutic; Therapeutic procedure; Time; Tissues; Training; Trauma; Treatment Efficacy; Viscosity; Visit; Visualization; Wait Time; cost; design; diagnostic value; drug efficacy; efficacious treatment; effusion; equipment training; experience; improved; improved mobility; joint mobilization; medical specialties; member; neurovascular; novel; obese patients; pain reduction; patient population; procedural pain; standard of care; success; tool; ultrasound

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.

抽象的 使用超声引导对关节内和关节外结构进行注射治疗是主要的治疗方法之一 可用于治疗肌肉骨骼 (MSK) 疼痛的药物治疗，但是，这些注射方法无法用于治疗 肥胖或无法长时间等待就诊专科中心的患者。正确的进针位置和 注射液的可视化对于骨科医生和运动医学医生执行这些操作非常重要 在美国为肥胖患者进行注射，以及进行培训和建立总体信心 医生可以在其初级保健办公室进行注射，从而改善注射服务。因此，本次活动的目标是 第一阶段项目是设计和开发用于输送空气微泡的 MSK ORBIS 造影装置 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。如果成功，部分好处将是改善获得 MSK 斯隆的机会 向肥胖患者注射，并通过可以在初级保健中进行注射的全科医生进行注射 诊所。其他好处可能包括更准确的注射，因此可以减少患者所经历的疼痛 患者进行注射所需的资源更少，并且对注射过程本身更有信心。 ORBIS 装置连接到充满药物的注射器末端，并立即产生分散液 注射时产生微泡。在初步尸体测试和台式测试中，ORBIS 设备 经证明可产生在超声波下产生回声并迅速消散的微泡，从而使 在错过关节内注射的情况下，提供者重新定位针头。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，包括一致的 微泡浓度、最佳回声性和可视化、消散以及与不同流体的使用 超声引导下髋关节和肩关节注射的粘度； 2) 验证临床应用 通过将台式数据与一系列临时尸体研究联系起来进行 ORBIS 设备设计 3) 在旨在评估 ORBIS 针头放置和注射准确性的研究中验证 ORBIS 利用具有不同经验水平的临床医生对尸体肩关节和髋关节进行研究。通过这些目标， ORBIS 的临床实用性将得到优化和验证，以提高从业人员的注射准确性。