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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

基本信息

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
项目类别：
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

项目摘要

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.

摘要