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Acta Metall Sin  2017, Vol. 53 Issue (10): 1227-1237    DOI: 10.11900/0412.1961.2017.00270
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Research Progress in Biodegradable Metals forStent Application
Yufeng ZHENG(), Hongtao YANG
Department of Materials Science and Engineering, College of Engineering, Peking University, Beijing 100871, China
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Yufeng ZHENG, Hongtao YANG. Research Progress in Biodegradable Metals forStent Application. Acta Metall Sin, 2017, 53(10): 1227-1237.

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Abstract  

During the last two decades, a great amount of researches have been focused on biodegradable metals. Technologies from alloy design to melting, manufacturing and processing, from micro-tube to stent laser processing and drug eluting coating have been improved and optimized continuously. Biodegradable metallic stent has evolved from a concept to a real product and generated three branches of material system. A large amount of animal tests and clinical tests have been carried out to investigate biodegradable magnesium stents. Results of clinical study have indicated that the magnesium stent is feasible, with favourable safety and performance outcomes. More importantly, Biotronik won CE Mark for Magmaris bioresorbable stent in 2016. Researches of biodegradable iron stents are still in the stage of animal tests. The nitrided iron stent possesses excellent mechanical properties. Results showed a good long-term biocompatibility of nitrided iron stent in rabbit and porcine model. Biodegradable zinc stent has only been introduced in recent years. Only a few in vivo studies have been reported with zinc wires implanted in rats. Results showed a good degradation behavior and biocompatibility of zinc wires. In this paper, the current research status of biodegradable metallic stents is reviewed, and the future research and development in mechanical property optimization, drug eluting and intelligence is proposed.
Key words:  biodegradable metallic stent      magnesium alloy      iron alloy      zinc alloy      biocompatibility      in vivo      degradation mechanism     
Received:  04 July 2017     
ZTFLH:  R318.08  
Fund: Supported by National Key Research and Development Program of China (No.2016YFC1102402) and National Natural Science Foundation of China (No.51431002)
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Yufeng ZHENG
Hongtao YANG

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https://www.ams.org.cn/EN/10.11900/0412.1961.2017.00270     OR     https://www.ams.org.cn/EN/Y2017/V53/I10/1227

Fig.1  Schematic diagram of degradation behavior and the change of mechanical integrity of biodegradable metallic stents during the vascular healing process[1]
Fig.2  SEM images (upper panels) and EDX mapping of AMS-3.0 degradation products (lower panels, unrelated to upper panels) (At 28 d, non-degraded magnesium-alloy particles had been surrounded by magnesium, calcium, and oxygen, probably in the form of MgCO3 or Mg(OH)2 or both, which could not be differentiated without further analysis. At 90 d, magnesium-alloy area was reduced, while oxidated (yellow) areas had become partly replaced at their outer margins by a calcium-phosphorous-oxygen compound (bluish area). Raman and infrared spectroscopy combined with X-ray diffraction analysis clarified that this was calcium phosphate with amorphous structure. At 180 d, no remaining metallic particles were noted)[23]
Criterion Constraint
Biodegradation Mechanical integrity for 3~6 months; Full absorption in 12~24 months
Biocompatibility Non-toxic and non-inflammatory; No allergenic potential; No harmful
release or retention of particles
Mechanical Yield strength>200 MPa; Ultimate tensile strength>300 MPa; Yield
properties strength : elastic modulus ratio>0.16; Elongation to failure>15%~18%;
Elastic recoil on expansion<4%
Microstructure Homogeneous and approximately isotopic
Small grain size <30 μm
Corrosion rate Penetration rate<0.02 mma-1
Table 1  Summary of material criteria and constraints for a biodegradable stent[9]
Test Stent system Experiment Biocompatibility Degradation Ref.
model time
Animal AE21 Domestic No thromboembolic events, 40% loss of 89 d [17]
test pigs, coronary lumen diameter corresponding to
artery neointimal formation, 25% re-enlargement
caused by vascular remodeling resulting
from the loss of mechanical integrity
between days 35 and 56
AZ91 Dogs, Lumen was clear and no elastic recoil and 7 d [18]
coronary or thrombosis, moderate intimal hyperplasia
femoral artery at 14 d
AZ31B Rabbits, Lumen area was significantly greater, the 120 d [19]
P(LA-TMC)+ abdominal neointimal area was significantly smaller
sirolimus aorta and endothelialization was delayed at 30 d
in coated group
WE43 Minipigs, Inhibitory effect on the smooth muscle 98 d [20]
coronary cells, rapid endothelialization, thin layer of
artery neointima covering the stent after 6 d,
degradation caused inflammation and
intimal hyperplasia
AMS Pigs, No signs of ongoing inflammation, 2 months [21]
coronary smallest lumen area at 3 months because
artery of negative vascular remodeling
AMS Pigs, Safe and with less neointimal formation - [22]
coronary compared with stainless stent, lumen area
artery did not change
AMS-3.0 Pigs, Equivalent to TAXUS Liberte regrading 180 d [23]
PLGA+ coronary late luminal loss, intimal area, fibrin
paclitaxel artery score and endothelialization. Inflammation
score was high at 28 d but disappeared at
later time
Clinical AMS Preterm baby, No relevant inflammatory reaction to the 5 months [24]
study pulmonary stent material, minimal alteration of the
artery vessel wall and an increase of the arterial
diameter after stenting
AMS Newborn, 15 d after implantation, blood velocity - [25]
aortic arch increased significantly, blood perfusion
recovered, lumen diameter increased
from 1.5~1.8 mm to 2~2.8 mm
AMS 20 patients The clinical patency rate was 89.5% after 3 - [26]
months, no blood toxicity was found
PROGRESS- 63 patients No myocardial infarction, subacute or late 4 months [27]
AMS thrombosis, or death. Angiography at 4
months showed an increased diameter
stenosis of 48.4. Overall target lesion
revascularization rate was 45% after 1 a.
Neointimal growth and negative
remodeling were the main mechanisms
of restenosis
Biosolve-I 46 patients Target lesion failure was 7% at 12 months. - [28]
DREAMS, A significant reduction of lumen area at 6
PLGA+ months and 12 months follow-up. No cardiac
paclitaxel death or scaffold thrombosis
Biosolve-II 123 patients A preservation of the scaffold area with a 12 months [8,29]
DREAMS 2G, low mean neointmal area. Target lesion
PLLA+ failure was 4%. No definite or probable
sirolimus scaffold thrombosis was observed. QCA
parameters remained stable from 6 months
to 12 months. Target lesion failure was
3.4% at 12 months
Table 2  In vivo tests of biodegradable Mg based stents[17-29]
Fig.2  SEM images (upper panels) and EDX mapping of AMS-3.0 degradation products (lower panels, unrelated to upper panels) (At 28 d, non-degraded magnesium-alloy particles had been surrounded by magnesium, calcium, and oxygen, probably in the form of MgCO3 or Mg(OH)2 or both, which could not be differentiated without further analysis. At 90 d, magnesium-alloy area was reduced, while oxidated (yellow) areas had become partly replaced at their outer margins by a calcium-phosphorous-oxygen compound (bluish area). Raman and infrared spectroscopy combined with X-ray diffraction analysis clarified that this was calcium phosphate with amorphous structure. At 180 d, no remaining metallic particles were noted)[23]
Stent system Animal model Biocompatibility Exp. period Ref.
Iron Rabbits, No thromboembolic complications, no 6~18 months [35]
descending adverse events. No significant neointimal
aorta proliferation, no pronounced inflammatory
response and no systemic toxicity
Iron Pigs, No signs of iron overload or iron-related organ 360 d [36]
descending aorta toxicity, no local or systemic toxicity
Iron Pigs, coronary At 28 d, no stent particle embolization or thrombosis 28 d [37]
artery and no excess inflammation, or fibrin deposition
Iron Rats, artery Substantial corrosion at 22 d, a voluminous 9 months [38]
lumen or wall corrosion product retained within the vessel
wall at 9 months. Implant in artery lumen
experienced minimal corrosion
Nitrided iron Minipigs, iliac Endothelialization after 1 month. Slightly lumen loss 12 months [39]
artery at 12 months. No thrombosis or local tissue necrosis
Nitrided iron Zn+ Rabbits, Complete endothelialization after 3 months, 13 months [40]
PDLLA+ abdominal slight inflammation during implantation,
sirolimus aorta no necrosis and systemic toxicity
Iron, nitrided iron Rabbits, Endothelialization after 7 d. Slight 53 months [7]
abdominal inflammation during implantation. No
aorta,pigs, necrosis and systemic toxicity. Corrosion
coronary artery products can be cleaned by macrophages
Table 3  In vivo tests of biodegradable Fe based stents[7,35-40]
Fig.3  SEM, EDS (a) and micro-CT (b) images of iron based scaffold (IBS) after 6 months implantation in rabbit abdominal aorta[34]
Implant Animal model Biocompatibility Experimental Ref.
period
Zinc Rat, abdominal Retained about 70% of its original cross 6 months [46]
wire aorta wall sectional area after 4 months, after which
degradation was observed to increase
rapidly. Corrosion products consisted
of ZnO, ZnCO3 and trace of Ca/P
Zinc Rat, abdominal A complete endothelial layer at 2.5 months 6 months [47]
wire aorta wall and stable appearance at 6.5 months.
Smooth muscle cells remained stable at
6.5 months, no pronounced chronic
inflammation
ZnAl Rat, abdominal No acute and chronic inflammatory were 6 months [48]
wire aorta wall presented, no necrosis. Cross-section was
reduction 40%~50% at 6 months
ZnAl Rat, abdominal Inflammatory cells were able to penetrate 6 months [49]
wire aorta wall the corrosion layer of ZnAl implant. A
delayed entrance of inflammatory cells
into corrosion layer of pure Zn was observed
ZnLi Rat, abdominal Degradation rates were 0.008 and 0.045 mm/a 12 months [50]
wire aorta wall at 2 and 12 months, respectively. No neointimal
hyperplasia. Inflammation and neointima
thickness was slightly higher for ZnLi than Zn
Zinc Rat, abdominal Intense fibrous encapsulation of the wire, steady 20 months [51]
wire aorta wall corrosion without local toxicity for up to 20
months. Chronic inflammation at 5~8 months
but subsided between 10~20 months
Zinc Rabbit, No severe inflammation, platelet aggregation, 12 months [52]
stent abdominal thrombosis formation or obvious intimal
aorta hyperplasia was observed
Table 4  In vivo tests of biodegradable Zn wires[46-52]
Fig.4  Zn-H2O (a) and Zn-C-H2O (b) Pourbaix diagrams for physiological concentrations at 310 K (The dotted lines show physiological pH of 7.4. The physiological potential for tissue fluid is indicated by circles. E—potential)[51]
Fig.5  Schematic diagrams showing the evolution of degradation mechanism of zinc stent associated with the conversion of degradation microenvironments during healing process(a, b) formation of zinc phosphate under the dynamic flow condition in blood fluid(c, d) conversion of zinc phosphate to ZnO and calcium phosphate under the diffusion condition in neointimal. SEM images corresponding to the related schematic diagrams are consisted of representative surface morphologies and cross-sections. The timeline depicts the healing process including inflammation, granulation and remodeling phases and selected time points. The models explain the formation of corrosion products and their dependence on local pH, distance from stent surface and implantation time in blood fluid (e) and neointimal (f). The red lines represent the assumed pH variation on the sample surface[52]
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