A recoil resilient lumen support, design, fabrication and mechanical evaluation

Stents are artificial implants that provide scaffolding to a cavity inside the body. This paper presents a new luminal device for reducing the mechanical failure of stents due to recoil, which is one of the most important issues in stenting. This device, which we call a recoil-resilient ring (RRR), is utilized standalone or potentially integrated with existing stents to address the problem of recoil. The proposed structure aims to minimize the need for high-pressure overexpansion that can induce intra-luminal trauma and excess growth of vascular tissue causing later restenosis. The RRR is an overlapped open ring with asymmetrical sawtooth structures that are intermeshed. These teeth can slide on top of each other, while the ring is radially expanded, but interlock step-by-step so as to keep the final expanded state against compressional forces that normally cause recoil. The RRRs thus deliver balloon expandability and, when integrated with a stent, bring both radial rigidity and longitudinal flexibility to the stent. The design of the RRR is investigated through finite element analysis (FEA), and then the devices are fabricated using micro-electro-discharge machining of 200-mu m-thick Nitinol sheet. The standalone RRR is balloon expandable in vitro by 5-7 Atm in pressure, which is well within the recommended in vivo pressure ranges for stenting procedures. FEA compression tests indicate 13 x less reduction of the cross-sectional area of the RRR compared with a typical stainless steel stent. These results also show perfect elastic recovery of the RRR after removal of the pressure compared to the remaining plastic deformations of the stainless steel stent. On the other hand, experimental loading tests show that the fabricated RRRs have 2.8 x radial stiffness compared to a two-column section of a commercial stent while exhibiting comparable elastic recovery. Furthermore, testing of in vitro expansion in a mock artery tube shows around 2.9% recoil, approximately 5-11 x smaller than the recoil reported for commercial stents. These experimental results demonstrate the effectiveness of the device design for the targeted luminal support and stenting applications.