SBIR-STTR Award

Injection therapy for intra and extra-articular structures using ultrasound guidance is one of the principalmedical treatments available for musculoskeletal (MSK) pain, however, these injections are inaccessible topatients who are obese or unable to wait a long time to visit a specialty center. Correct needle placement andvisualization of the injectate is important to enable orthopedists and sports medicine doctors to perform theseinjections in obese patients under US, as well as to enable training and build confidence in generalpractitioners to conduct injections in their primary care offices, thus improving access. As such, the goal of thisPhase 1 project is to design and develop the MSK ORBIS Contrast Device for delivery of microbubbles of airmixed in therapeutic cocktails for use as a tool to increase the accuracy and reduce the level of trainingneeded for MSK injection procedures. If successful, the benefit, in part, would be improved access to MSKinjections to obese patients and through general practitioners that can perform the injections in a primary careclinic. Other benefits potentially include more accurate injections and as such, less pain experienced bypatients, 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 ofmicrobubbles during injection. In preliminary cadaver testing and benchtop testing, the ORBIS device wasshown to produce microbubbles that are echogenic under ultrasound and dissipate quickly, allowing theprovider to reposition the needle in cases of missed intra-articular injections. The specific aims of this proposalare as follows: 1) develop and test the MSK ORBIS device to meet design criteria including consistentmicrobubble concentration, optimal echogenicity and visualization, dissipation, and use with fluids of differentviscosities for hip and shoulder joint injections under ultrasound guidance; 2) verify the clinical utility of theORBIS 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 ORBISin cadaver shoulder and hip joints utilizing clinicians with varied experience levels. Through these aims, theclinical utility of the ORBIS will be optimized and validated for improving injection accuracy for practitioners.

Public Health Relevance Statement:
Project Narrative Musculoskeletal (MSK) injections are a common therapeutic procedure performed in specialty centers for delivery of localized anesthetic, corticosteroids, or lubricants like hyaluronic acid to reduce pain and inflammation, as well as improve mobility of joints. Confirmation of correct needle placement under ultrasound is important for therapeutic efficacy of the drug, reduction of procedural pain, and correct diagnosis of conditions like effusion. Current standard of care for needle placement confirmation, either through palpation, US visualization of anatomical structures, or fluoroscopy, is rapt with operating inefficiencies because of its difficulty to perform, especially in obese patients, and is unavailable in primary care clinics. To enable access to ultrasound guided MSK injections, the novel ORBIS device is proposed by Agitated Solutions. The ORBIS increases the echogenicity of MSK injectates to provide instantaneous feedback of needle placement under ultrasound, allowing specialists to use this technique on patients with an otherwise contra-indicated body habitus, as well as allow general practitioners to be trained on performing MSK injections to reduce secondary referral burden. The ORBIS will ultimately reduce pain during injection procedures, increase efficacy of the therapeutic injectate, and improve accessibility to MSK injections to obese patients and through non-specialists training and use of the device.

Project Terms: