Research on elastic recoil and restoration of vessel pulsatility of Zn-Cu biodegradable coronary stents.

Coronary stents made of zinc (Zn)-0.8 copper (Cu) (in wt%) alloy were developed as biodegradable metal stents (Zn-Cu stents) in this study. The mechanical properties of the Zn-Cu stents and the possible gain effects were characterized by in vitro and in vivo experiments compared with 316L stainless steel stents (316L stents). Young's modulus of the as-extruded Zn-0.8Cu alloy and properties of the stents, including their intrinsic elastic recoil, stent trackability were evaluated compared with 316L stents. In vivo study was also conducted to evaluate restoration of pulsatility of vessel segment implanted stents. Both Zn-Cu stents and 316L stents have good acute lumen gain. By comparison, the advantages of Zn-Cu stents are as follows: (I) Zn-Cu stents have less intrinsic elastic recoil than 316L stents; (II) stent trackability indicates that Zn-Cu stents have a smaller push force when passing through curved blood vessels, which may cause less mechanical stimulation to blood vessels; (III) in vivo study suggests that Zn-Cu stents implantation better facilitates the recovery of vascular pulsatility.

Ultrasound controlled paclitaxel releasing system-A novel method for improving the availability of coronary artery drug coated balloon.

OBJECTIVES: The aim of this study is to improve local-drug delivery efficiency and tissue absorption using the ultrasound (US)-responsible drug coating based on a newly developed US-controlled paclitaxel release balloon. BACKGROUND: Low availability of the drug coating remains a major concern of the current drug coated balloon (DCB). The goal of this study is to develop a method to use an US-responsible paclitaxel-loaded microcapsules (PM) as the main content of balloon drug coating to enhance bioavailability of DCB. METHODS: An US-controlled paclitaxel release balloon is designed and fabricated based on the US-responsible paclitaxel-loaded poly (lactic-co-glycolic acid) (PLGA) microcapsules. Rapid exchange percutaneous transluminal coronary angioplasty (PTCA) balloon catheters were coated with the PM. The deployment processes of the paclitaxel-loaded microcapsules coated balloons (PMCB) under US, PMCB without US and a homogenous matrix of paclitaxel and iopromide coated balloon (PICB) were then placed in healthy and stent implanted porcine coronary arteries. RESULTS: In vitro release assay demonstrated an ability of US (1 MHz, 1.22 W/cm2 , 1 minute) to affect the release kinetics of paclitaxel from PM by inducing a 76 ± 5.4% increase in the rate of release. The paclitaxel content in target vessels are 203 ± 37 µg/g for PMCB under US, 85 ± 23 µg/g for PMCB without US, and 107 ± 31 µg/g for PICB 1-hr post-surgery. The availability of the drug for the PMCB reaches 27% under US. CONCLUSIONS: The US-controlled paclitaxel release balloon significantly improved the drug content of the target vessels in the porcine model.

Long-term in vivo study of biodegradable Zn-Cu stent: A 2-year implantation evaluation in porcine coronary artery.

In the present study, a novel biodegradable Zn-0.8Cu coronary artery stent was fabricated and implanted into porcine coronary arteries for up to 24 months. Micro-CT analysis showed that the implanted stent was able to maintain structural integrity after 6 months, while its disintegration occurred after 9 months of implantation. After 24 months of implantation, approximately 28 ±â€¯13 vol% of the stent remained. Optical coherence tomography and histological analysis showed that the endothelialization process could be completed within the first month after implantation, and no inflammation responses or thrombosis formation was observed within 24 months. Cross-section analysis indicated that the subsequent degradation products had been removed in the abluminal direction, guaranteeing that the strut could be replaced by normal tissue without the risk of contaminating the circulatory system, causing neither thrombosis nor inflammation response. The present work demonstrates that the Zn-0.8Cu stent has provided sufficient structural supporting and exhibited an appropriate degradation rate during 24 months of implantation without degradation product accumulation, thrombosis, or inflammation response. The results indicate that the Zn-0.8Cu coronary artery stent is promising for further clinical applications. STATEMENT OF SIGNIFICANCE: Although Zn and its alloys have been considered to be potential candidates of biodegradable metals for vascular stent use, by far, no Zn-based stent with appropriate medical device performance has been reported because of the low mechanical properties of zinc. The present work presents promising results of a Zn-Cu biodegradable vascular stent in porcine coronary arteries. The Zn-Cu stent fabricated in this work demonstrated adequate medical device performance both in vitro and in vivo and degraded at a proper rate without safety problems induced. Furthermore, large animal models have more cardiovascular similarities as humans. Results of this study may provide further information of the Zn-based stents for translational medicine research.