Development of a polycaprolactone/poly(p-dioxanone) bioresorbable stent with mechanically self-reinforced structure for congenital heart disease treatment

Abstract

Recent progress in bioresorbable stents (BRSs) has provided a promising alternative for treating coronary artery disease. However, there is still lack of BRSs with satisfied compression and degradation performance for pediatric patients with congenital heart disease, leading to suboptimal therapy effects. Here, we developed a mechanically self-reinforced composite bioresorbable stent (cBRS) for congenital heart disease application. The cBRS consisted of poly( p -dioxanone) monofilaments and polycaprolactone/poly( p -dioxanone) core-shell composite yarns. Interlacing points in cBRS structure were partially bonded, offering the cBRS with significantly higher compression force compared to typical braids and remained good compliance. The suitable degradation profile of the cBRS can possibly preserve vascular remodeling and healing process. In addition, the controllable structural organization provides a method to customize the performance of the cBRS by altering the proportion of different components in the braids. The in vivo results suggested the cBRS supported the vessel wall similar to that of metallic stent. In both abdominal aorta and iliac artery of porcine, cBRS was entirely endothelialized within 1 month and maintained target vessels with good patency in the 12-month follow-up. The in vivo degradation profile of the cBRS is consistent with static degradation results in vitro. It is also demonstrated that there is minimal impact of pulsatile pressure of blood flow and variation of radial force on the degradation rate of the cBRS. Moreover, the lumen of cBRS implanted vessels were enlarged after 6 months, and significantly larger than the vessels implanted with metallic stent in 12 months.

Cardiovascular Stents: A Review of Past, Current, and Emerging Devices

“…It is in this regard that biocompatible, biodegradable polymers and metallic materials have attracted increased attention [ 32 , 84 ] ( Table 2 ). Manufacturing methods include, but are not limited to, photochemical etching [ 85 , 86 ], helical coiling [ 87 , 88 ], braiding techniques [ 89 , 90 , 91 ], fluid dispensing [ 92 ], three-dimensional (3D) printing [ 93 , 94 ], electrospinning [ 95 , 96 ], hot extrusion [ 97 ], and selective laser melting [ 98 ].…”

“…It is in this regard that biocompatible, biodegradable polymers and metallic materials have attracted increased attention [32,84] (Table 2). Manufacturing methods include, but are not limited to, photochemical etching [85,86], helical coiling [87,88], braiding techniques [89][90][91], fluid dispensing [92], three-dimensional (3D) printing [93,94], electrospinning [95,96], hot extrusion [97], and selective laser melting [98]. Abbreviations: PLA-polylactic acid; PDLLA-poly-DL-lactic acid; PLLA-poly-L-lactic acid; PGA-polyglycolide; PDLGA-poly-DL-lactide-co-glycolide; PLGA-poly-lactic-co-glycolide; PCL-polycaprolactone; PLA/PCL-polylactic acid/polycaprolactone; PCpolycarbonates; AE21-magnesium alloy containing~2% aluminum and~1% rare earth metals; AE42-magnesium alloy containing~4% aluminum and~2% rare earth metals; WE43-magnesium alloy containing 4.2% yttrium, 2.4% neodymium, 0.6% cerium/lanthanum, and 0.5% zirconium; AZ31-magnesium alloy containing~3% aluminum and~1% zinc.…”

Biodegradable Iron-Based Materials—What Was Done and What More Can Be Done?

“…In 2016, the Absorb drug-eluting device, based on PLLA, was the first bioresorbable cardiovascular scaffold approved for use in the United States by the U.S. Food and Drug Administration [ 2 ]. Other biodegradable polymers and copolymers used for research include: poly(ε-caprolactone) (PCL), poly( l -lactide-co-ε-caprolactone) (PLCL), phosphoryl choline (ChoP), poly(desaminotyrosyl-tyrosine ethyl ester) carbonate (PTD-PC), poly(anhydride ester) (PAE), poly( d , l -lactide-co-glycolide) (PLGA), and poly(vinylidenefluoride)-hexafluoropropylene (PVDF-HFP) [ 6 , 13 , 15 , 16 , 17 , 18 ]. Despite very promising results, the polymers also have several disadvantages that limit their use.…”

Translation of biomaterials from bench to clinic

“…A total of 24 articles [ [4] , [5] , [6] , [7] , [8] , [9] , [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] ] are included in this special issue. These articles can be categorized in terms of authors, biomaterials and targeted clinical areas, and article types.…”

“…Several articles in this special issue are on regulatory science and discuss the new standards, tools, and approaches to evaluate the safety, efficacy, quality, and performance of medical products [ 10 , 13 , 17 , 19 ]. This special issue also covers a wide range of article types including research article [ [1] , [2] , [3] , [4] , [5] , [6] , [7] , [8] , [9] , 11 , 12 , 15 , 16 , [18] , [19] , [20] , [23] , [24] , [25] , [26] ], reviews [ 14 , 17 , 21 , 22 , 27 ], perspectives [ 10 , 13 ] and opinion paper [ 18 ].…”