Date of Graduation

5-2022

Document Type

Thesis

Degree Name

Bachelor of Science in Biomedical Engineering

Degree Level

Undergraduate

Department

Biomedical Engineering

Advisor/Mentor

Jensen, Morten

Abstract

Coronary artery disease is the most common form of heart disease and the leading cause of death in the U.S. ("Heart Disease Facts | cdc.gov", 2021). Typically, coronary artery disease is a result of coronary stenosis, constriction of the coronary artery, which can cause heart failure, arrhythmia, or heart attack ("Coronary Artery Disease: Prevention, Treatment and Research", 2021). Angioplasty balloons are a common treatment method for coronary stenosis and work by placing a stent at the lesion site to widen the vessel and promote blood flow. A type of lesion which remains particularly difficult and relatively common to treat is a bifurcation lesion (Rizik, 2021). Current stenting methods for bifurcation lesions use standard-shaped angioplasty balloons and can result in restenosis through overlapping stents or exposed artery locations. In response, tapered balloons that better fit the bifurcation geometry are being examined for potential use in intervention treatments (Uretsky, 2014).

Previous research in this project developed a prototype balloon-forming machine and customizable molds which did produce bifurcation-specific angioplasty balloons (Elmer et. al., 2022). However, the prototype produced balloons that were significantly larger than the typical sizes used in clinical settings. This project examined the effects of reducing the mold size diameter from 16 mm to 9 mm on the machine and balloon forming process. Formation variables, such as heat time, pressure, and temperature, were tested across various ranges, which highlighted issues in the procedure such as tubing dimensions and luer lock connections. These were corrected by developing a new tubing necking device and process to produce tubing with tapered ends. A setting rack was designed to correct luer lock connections. The resulting parisons and procedures were more closely adapted to standard industry practices. Further research and testing will have to be conducted to improve the tubing end seal.

Keywords

coronary artery disease; balloon angioplasty; bifurcation lesion

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