IP Requirement: Emory IP

Experience Requirement:

– Mechanical Design

– Rapid Prototyping

Interventional radiology (IR) and image-guided medicine (IGM) continue to impact patients throughout the world. Transarterial and transvenous procedures (procedures that require access to an artery or vein) include: uterine artery embolization for abnormal bleeding due to fibroids and/or postpartum hemorrhage, prostate artery embolization for treatment of symptoms related to an enlarged prostate, treatment of tumor in the liver with tiny spheres coated in radiation or chemotherapy, and treatment of life-threatening internal bleeding either in the setting of trauma or gastrointestinal bleeding, placement of stents in the venous system where there is severe narrowing, use of materials to “scar down” abnormal tangle of vessels or veins (such as in the setting of varices or vascular anomalies), among other procedures. Procedures are also performed in the biliary and urinary systems, in addition to virtually everywhere in the body.

Fluoroscopy is the mainstay of imaging for IR procedures. While ultrasound and CT are also utilized, each has limitations for some procedures in isolation. Ultrasound has limited tissue penetration. CT utilizes a “static” image (“take a picture and guess your next move” rather than watching what is happening in real-time). MRI-guided procedures, while performed, are rare, costly, and limited. Fluoroscopy uses ionizing radiation to be able to visualize in real-time what is happening in the body. A principle utilized to reduce risk of harm from ionizing radiation to patient and operators in the room is ALARA – as low as reasonably achievable. We often start with the machine at the “lowest doses” to see what we need to see and “ramp up” as necessary.

Nevertheless, visualization can be challenging. To see a small wire or catheter or other object, we may be increasing dose that has the potential to jeopardize everyone in the room (especially the patient) and/or overheat the machine. Older machines may make visualization very difficult. Even with AI software algorithms in newer equipment, some wires and catheters remain difficult to visualize. Older, more experienced IR’s may have more trouble visualizing what is needed as we age. We have a few recent case examples – one sponsor (ZLB) was involved in a robotic wire project where despite benchtop testing showing a wire to be “radiopaque enough,” it was difficult to visualize when tested in a pig using an older animal facility angiosuite. The same sponsor also deployed a newly approved “resorbable” stent in a patient recently that was very difficult to visualize even in a new angiosuite with advanced AI algorithms. Some devices (specific microcatheters, microvascular plugs, etc.) are just very difficult to visualize.

While an “easy” solution may be to tell companies to simply put far more radiopacity in their devices before they hit market, there are barriers including: limitations on what can be placed in the device due to size or materials; challenges with the regulatory process, and variability where visualization on one newer machine may not mean visualization on an older piece of equipment. An ideal solution could help render pre-existing machines more easily visualizable and help “democratize” the visualization piece whereby those with access to older equipment or have more difficulty viewing can use the solution to improve what they can see. It would be “vendor agnostic” and help regardless of the make or model of equipment or materials used.

The team will be encouraged to observe procedures in our new state-of-the-art operation at the Winship at Emory Midtown Tower and at the renowned Emory University Hospital campus and to think about how to democratize subspecialty care between world renown medical centers and community practices to address health inequity through novel devices.