Next Generation DCB Catheter — Adjustable, No Shear, Evaginating DCB Design

Known limitations of drug-coated balloons (DCBs) include loss of drug during catheter transit through the sheath, guide catheter and vasculature, the need for precise sizing of the balloon to the artery segment being treated, and fixed balloon sizes (lengths and diameters). These limitations not only effect the safety and efficacy of the device, but since multiple DCBs are often required, their use results in additional costs, fluoroscopy, contrast and procedure time. To address the limitations of DCBs, a new balloon catheter platform is presented which comprises an adjustable, no-shear, evaginating balloon design. The design incorporates a single balloon to treat continuous vessel segment lengths from 1-30+ cm. The balloon adapts to the vessel diameter to avoid balloon/artery sizing concerns, and can treat multiple diameters, such as found in tapered vessels and complex lesions, to provide ideal balloon/drug contact. No shear forces are generated during balloon placement and deployment. The balloon/drug is protected during catheter advancement to prevent drug loss and provide more time to get to the lesion. Upon deployment, the balloon initially occludes the vessel proximal to the lesion to prevent drug washout, and then unrolls through the lesion and expands radially to avoid vascular shear injury. The compliant nature of the balloon provides very low pressure atraumatic balloon drug delivery, which further lowers the risk of dissection and vascular injury. This new platform offers a promising solution to the limitations of current drug eluting/coated devices.