Endoscopic submucosal dissection (ESD) of superficial esophageal cancer has been increasingly used as an alternative to surgery because it is minimally invasiveand has a high rate of en bloc resection. However, a high...Endoscopic submucosal dissection (ESD) of superficial esophageal cancer has been increasingly used as an alternative to surgery because it is minimally invasiveand has a high rate of en bloc resection. However, a high rate of esophageal stricture is observed after ESD for large lesions, which can dramatically decrease the patient's quality of life. Stricture prevention is necessary to allow for endoscopic therapy to expand. We, herein, review the most recent evidence and discuss the role of the metallic self-expandable stent and the biodegradable stent in esophageal stricture prevention. Limited studies suggested that prophylactic stenting could reduce the stricture rate without increasing the number of complications. In addition, the number of bougie dilation procedures was significantly lower with stent placement. Esophageal stenting is a promising option for post-ESD stricture prevention. However, current evidence is too preliminary to formulate practice standards. Future studies are needed to further validate the efficacy and safety of prophylactic stenting and determine the best strategy for stricture prevention. Stent migration is the most common complication. A new stent that has advantages of a low migration rate and minimal tissue reaction will need to be developed. Therefore, randomized controlled trials with long-term follow-up periods are required before prophylactic stenting could be considered a valid option to prevent post-ESD stricture.展开更多
This article describes the evolution of minimally invasive intervention technologies for vascular restoration therapy from early-stage balloon angioplasty in 1970s,metallic bare metal stent and metallic drug-eluting s...This article describes the evolution of minimally invasive intervention technologies for vascular restoration therapy from early-stage balloon angioplasty in 1970s,metallic bare metal stent and metallic drug-eluting stent technologies in 1990s and 2000s,to bioresorbable vascular scaffold(BVS)technology in large-scale development in recent years.The history,the current stage,the challenges and the future of BVS development are discussed in detail as the best available approach for vascular restoration therapy.The criteria of materials selection,design and processing principles of BVS,and the corresponding clinical trial results are also summarized in this article.展开更多
Background To overcome the drawbacks of permanent years. The bioabsorbable polymer vascular scaffold (BVS) stents, biodegradable stents have been studied in recent was the first bioabsorbable stent to undergo clinic...Background To overcome the drawbacks of permanent years. The bioabsorbable polymer vascular scaffold (BVS) stents, biodegradable stents have been studied in recent was the first bioabsorbable stent to undergo clinical trials, demonstrating safety and feasibility in the ABSORB studies. Iron can potentially serve as the biomatedal for biodegradable stents. This study aimed to assess the short4erm safety and efficacy of a biodegradable iron stent in mini-swine coronary arteries. Methods Eight iron stents and eight cobalt chromium alloy (VISION) control stents were randomly implanted into the LAD and RCA of eight healthy mini-swine, respectively. Two stents of the same metal base were implanted into one animal. At 28 days the animals were sacrificed after coronary angiography, and histopathological examinations were performed. Results Histomorphometric measurements showed that mean neointimal thickness ((0.46±0.17) mm vs. (0.45±0.18) mm, P=0.878), neointimal area ((2.55±0.91) mm2 vs. (3.04±1.15) mm2, P=0.360) and percentage of area stenosis ((44.50±11.40)% vs. (46.00±17.95)%, P=0.845) were not significantly different between the iron stents and VISION stents. There was no inflammation, thrombosis or necrosis in either group. The scanning electron microscopy (SEM) intimal injury scores (0.75±1.04 vs. 0.88±0.99, P=0.809) and number of proliferating cell nuclear antigen (PCNA) positive staining cells were not significantly different between the two groups. The percentage of neointimal coverage by SEM examination was numerically higher in iron stents than in VISION stents ((84.38±14.50)% vs. (65.00±22.04)%, P=0.057), but the difference was not statistically significant. Iron staining in the tissue surrounding the iron stents at 28 days was positive and the vascular wall adjacent to the iron stent had a brownish tinge, consistent with iron degradation. No abnormal histopathological changes were detected in coronary arteries or major organs. Conc展开更多
The study is concerned with the mechanical properties of Zn and three Zn–Mg double alloys with Mg concentrations:0.5%,1.0%and 1.5%in the form of rods with a diameter of 5 mm as potential materials for use in biodegra...The study is concerned with the mechanical properties of Zn and three Zn–Mg double alloys with Mg concentrations:0.5%,1.0%and 1.5%in the form of rods with a diameter of 5 mm as potential materials for use in biodegradable medical implants,such as vascular stents.The materials were cast,next conventionally hot extruded at 250°C and finally,hydrostatically extruded(HE)at ambient temperature.Occasionally HE process was carried at liquid nitrogen temperature or in combination with the ECAP process.After HE,the microstructure of the alloys was made up of fine-grainedαZn of mean grain size~1μm in a 2-phase coat of 50–200 nm nanograins of the fineαZn+Mg2Zn11 eutectic.The 3 to 4-fold reduction of grain size as a result of HE allowed an increase in yield strength from 100%to over 200%,elongation to fracture from 100%to thirty fold and hardness over 50%compared to the best literature results for similar alloys.Exceptions accounted for elongation to fracture in case of Zn-0.5 Mg alloy and hardness in case of Zn-1.5 Mg alloy,both of which fell by 20%.For the Zn-0.5 Mg and Zn–1Mg alloys,after immersion tests,no corrosive degradation of plasticity was observed.Achieving these properties was the result of generating large plastic deformations at ambient temperature due to the application of high pressure forming with the cumulative HE method.The results showed that Zn–Mg binary alloys after HE have mechanical and corrosive characteristics,qualifying them for applications in biodegradable implants,including vascular stents.展开更多
BACKGROUND Stent insertion can effective alleviate the symptoms of benign esophageal strictures(BES).Magnesium alloy stents are a good candidate because of biological safety,but show a poor corrosion resistance and a ...BACKGROUND Stent insertion can effective alleviate the symptoms of benign esophageal strictures(BES).Magnesium alloy stents are a good candidate because of biological safety,but show a poor corrosion resistance and a quick loss of mechanical support in vivo.AIM To test the therapeutic and adverse effects of a silicone-covered magnesium alloy biodegradable esophageal stent.METHODS Fifteen rabbits underwent silicone-covered biodegradable magnesium stent insertion into the benign esophageal stricture under fluoroscopic guidance(stent group).The wall reconstruction and tissue reaction of stenotic esophagus in the stent group were compared with those of six esophageal stricture models(control group).Esophagography was performed at 1,2,and 3 weeks.Four,six,and five rabbits in the stent group and two rabbits in the control groups were euthanized,respectively,at each time point for histological examination.RESULTS All stent insertions were well tolerated.The esophageal diameters at immediately,1,2 and 3 wk were 9.8±0.3 mm,9.7±0.7 mm,9.4±0.8 mm,and 9.2±0.5 mm,respectively(vs 4.9±0.3 mm before stent insertion;P<0.05).Magnesium stents migrated in eight rabbits[one at 1 wk(1/15),three at 2 wk(3/11),and four at 3 wk(4/5)].Esophageal wall remodeling(thinner epithelial and smooth muscle layers)was found significantly thinner in the stent group than in the control group(P<0.05).Esophageal injury and collagen deposition following stent insertion were similar and did not differ compared to rabbits with esophageal stricture and normal rabbits(P>0.05).CONCLUSION Esophageal silicone-covered biodegradable magnesium stent insertion is feasible for BES without causing severe injury or tissue reaction.Our study suggests that insertion of silicone-covered magnesium esophageal stent is a promising approach for treating BES.展开更多
Background Drug eluting stents (DESs) made with biodegradable polymer have been developed in an attempt to improve clinical outcomes.However,the impact of biodegradable polymers on clinical events and stent thrombos...Background Drug eluting stents (DESs) made with biodegradable polymer have been developed in an attempt to improve clinical outcomes.However,the impact of biodegradable polymers on clinical events and stent thrombosis (ST) remains controversial.Methods We searched Medline,the Cochrane Library and other internet sources,without language or date restrictions for articles comparing clinical outcomes between biodegradable polymer DES and durable polymer DES.Safety endpoints were ST (definite,definite/probable),mortality,and myocardial infarction (MI).Efficacy endpoints were major adverse cardiac event (MACE) and target lesion revascularization (TLR).Results We identified 15 randomized controlled trials (n=17 068) with a weighted mean follow-up of 20.6 months.There was no statistical difference in the incidence of definite/probable ST between durable polymer-and biodegradable polymerDES; relative risk (RR) 0.83; 95% confidence interval (CI) 0.62-1.11; P=0.22.Biodegradable polymer DES had similar rates of definite ST (RR 0.94,95% CI 0.66-1.33,P=0.72),mortality (RR 0.94,95% C/0.82-1.09,P=0.43),MI (RR 1.08,95% CI 0.92-1.26.P=0.35),MACE (RR 0.99,95% CI 0.91-1.09,P=0.85),and TLR (RR,0.94,95% CI 0.83-1.06,P=0.30) compared with durable polymer DES.Based on the stratified analysis of the included trials,the treatment effect on definite ST was different at different follow-up times:≤1 year favoring durable polymer DES and 〉1 year favoring biodegradable polymer DES.Conclusions Biodegradable polymer DES has similar safety and efficacy for treating patients with coronary artery disease compared with durable polymer DES.Further data with longer term follow-up are warranted to confirm the potential benefits of biodegradable polymer DES.展开更多
A stent is a medical device designed to serve as a temporary or permanent internal scaffold to maintain or increase the lumen of a body conduit. The researcher;~ and engineers diverted to investigate biodegradable mat...A stent is a medical device designed to serve as a temporary or permanent internal scaffold to maintain or increase the lumen of a body conduit. The researcher;~ and engineers diverted to investigate biodegradable materials due to the limitation of metallic materials in stent application such as stent restenosis which requires prolonged anti platelet therapy, often result in smaller lumen after implantation and obstruct re-stenting treatments. Biomedical implants with temporary function for the vascular intervention are extensively studied in recent years. The rationale for biodegradable stent is to provide the support for the vessel in predicted period of time and then degrading into biocompatible constituent. The degradation of stent makes the re-stenting possible after several months and also ameliorates the vessel wall quality. The present article focuses on the biodegradable materials for the cardiovascular stent. The objective of this review is to describe the possible biodegradable materials for stent and their properties such as design criteria, degradation behavior, drawbacks and advantages with their recent clinical and preclinical trials.展开更多
Biliary stricture is defined as the reduction and narrowing of the bile duct lumen, which can be caused by many factors such as cancer and inflammation. Biliary stent placement can effectively alleviate benign and mal...Biliary stricture is defined as the reduction and narrowing of the bile duct lumen, which can be caused by many factors such as cancer and inflammation. Biliary stent placement can effectively alleviate benign and malignant biliary strictures. However, the commonly used plastic or metallic biliary stents are far from ideal and do not satisfy all clinical requirements,although several types of biodegradable biliary stents have been developed and used clinically. In this review, we summarized current development status of biodegradable stents with the emphasis on the stent materials. We also presented the future development trends based on the published literature.展开更多
文摘Endoscopic submucosal dissection (ESD) of superficial esophageal cancer has been increasingly used as an alternative to surgery because it is minimally invasiveand has a high rate of en bloc resection. However, a high rate of esophageal stricture is observed after ESD for large lesions, which can dramatically decrease the patient's quality of life. Stricture prevention is necessary to allow for endoscopic therapy to expand. We, herein, review the most recent evidence and discuss the role of the metallic self-expandable stent and the biodegradable stent in esophageal stricture prevention. Limited studies suggested that prophylactic stenting could reduce the stricture rate without increasing the number of complications. In addition, the number of bougie dilation procedures was significantly lower with stent placement. Esophageal stenting is a promising option for post-ESD stricture prevention. However, current evidence is too preliminary to formulate practice standards. Future studies are needed to further validate the efficacy and safety of prophylactic stenting and determine the best strategy for stricture prevention. Stent migration is the most common complication. A new stent that has advantages of a low migration rate and minimal tissue reaction will need to be developed. Therefore, randomized controlled trials with long-term follow-up periods are required before prophylactic stenting could be considered a valid option to prevent post-ESD stricture.
文摘This article describes the evolution of minimally invasive intervention technologies for vascular restoration therapy from early-stage balloon angioplasty in 1970s,metallic bare metal stent and metallic drug-eluting stent technologies in 1990s and 2000s,to bioresorbable vascular scaffold(BVS)technology in large-scale development in recent years.The history,the current stage,the challenges and the future of BVS development are discussed in detail as the best available approach for vascular restoration therapy.The criteria of materials selection,design and processing principles of BVS,and the corresponding clinical trial results are also summarized in this article.
文摘Background To overcome the drawbacks of permanent years. The bioabsorbable polymer vascular scaffold (BVS) stents, biodegradable stents have been studied in recent was the first bioabsorbable stent to undergo clinical trials, demonstrating safety and feasibility in the ABSORB studies. Iron can potentially serve as the biomatedal for biodegradable stents. This study aimed to assess the short4erm safety and efficacy of a biodegradable iron stent in mini-swine coronary arteries. Methods Eight iron stents and eight cobalt chromium alloy (VISION) control stents were randomly implanted into the LAD and RCA of eight healthy mini-swine, respectively. Two stents of the same metal base were implanted into one animal. At 28 days the animals were sacrificed after coronary angiography, and histopathological examinations were performed. Results Histomorphometric measurements showed that mean neointimal thickness ((0.46±0.17) mm vs. (0.45±0.18) mm, P=0.878), neointimal area ((2.55±0.91) mm2 vs. (3.04±1.15) mm2, P=0.360) and percentage of area stenosis ((44.50±11.40)% vs. (46.00±17.95)%, P=0.845) were not significantly different between the iron stents and VISION stents. There was no inflammation, thrombosis or necrosis in either group. The scanning electron microscopy (SEM) intimal injury scores (0.75±1.04 vs. 0.88±0.99, P=0.809) and number of proliferating cell nuclear antigen (PCNA) positive staining cells were not significantly different between the two groups. The percentage of neointimal coverage by SEM examination was numerically higher in iron stents than in VISION stents ((84.38±14.50)% vs. (65.00±22.04)%, P=0.057), but the difference was not statistically significant. Iron staining in the tissue surrounding the iron stents at 28 days was positive and the vascular wall adjacent to the iron stent had a brownish tinge, consistent with iron degradation. No abnormal histopathological changes were detected in coronary arteries or major organs. Conc
基金the National Science Centre(Poland),grant UMO-2016/23/B/ST8/00724.
文摘The study is concerned with the mechanical properties of Zn and three Zn–Mg double alloys with Mg concentrations:0.5%,1.0%and 1.5%in the form of rods with a diameter of 5 mm as potential materials for use in biodegradable medical implants,such as vascular stents.The materials were cast,next conventionally hot extruded at 250°C and finally,hydrostatically extruded(HE)at ambient temperature.Occasionally HE process was carried at liquid nitrogen temperature or in combination with the ECAP process.After HE,the microstructure of the alloys was made up of fine-grainedαZn of mean grain size~1μm in a 2-phase coat of 50–200 nm nanograins of the fineαZn+Mg2Zn11 eutectic.The 3 to 4-fold reduction of grain size as a result of HE allowed an increase in yield strength from 100%to over 200%,elongation to fracture from 100%to thirty fold and hardness over 50%compared to the best literature results for similar alloys.Exceptions accounted for elongation to fracture in case of Zn-0.5 Mg alloy and hardness in case of Zn-1.5 Mg alloy,both of which fell by 20%.For the Zn-0.5 Mg and Zn–1Mg alloys,after immersion tests,no corrosive degradation of plasticity was observed.Achieving these properties was the result of generating large plastic deformations at ambient temperature due to the application of high pressure forming with the cumulative HE method.The results showed that Zn–Mg binary alloys after HE have mechanical and corrosive characteristics,qualifying them for applications in biodegradable implants,including vascular stents.
基金Supported by the National Natural Science Foundation of China,No.81371659,No.81571773,and No.81771943Shanghai Municipal Health and Family Planning Commission,No.201640191
文摘BACKGROUND Stent insertion can effective alleviate the symptoms of benign esophageal strictures(BES).Magnesium alloy stents are a good candidate because of biological safety,but show a poor corrosion resistance and a quick loss of mechanical support in vivo.AIM To test the therapeutic and adverse effects of a silicone-covered magnesium alloy biodegradable esophageal stent.METHODS Fifteen rabbits underwent silicone-covered biodegradable magnesium stent insertion into the benign esophageal stricture under fluoroscopic guidance(stent group).The wall reconstruction and tissue reaction of stenotic esophagus in the stent group were compared with those of six esophageal stricture models(control group).Esophagography was performed at 1,2,and 3 weeks.Four,six,and five rabbits in the stent group and two rabbits in the control groups were euthanized,respectively,at each time point for histological examination.RESULTS All stent insertions were well tolerated.The esophageal diameters at immediately,1,2 and 3 wk were 9.8±0.3 mm,9.7±0.7 mm,9.4±0.8 mm,and 9.2±0.5 mm,respectively(vs 4.9±0.3 mm before stent insertion;P<0.05).Magnesium stents migrated in eight rabbits[one at 1 wk(1/15),three at 2 wk(3/11),and four at 3 wk(4/5)].Esophageal wall remodeling(thinner epithelial and smooth muscle layers)was found significantly thinner in the stent group than in the control group(P<0.05).Esophageal injury and collagen deposition following stent insertion were similar and did not differ compared to rabbits with esophageal stricture and normal rabbits(P>0.05).CONCLUSION Esophageal silicone-covered biodegradable magnesium stent insertion is feasible for BES without causing severe injury or tissue reaction.Our study suggests that insertion of silicone-covered magnesium esophageal stent is a promising approach for treating BES.
文摘Background Drug eluting stents (DESs) made with biodegradable polymer have been developed in an attempt to improve clinical outcomes.However,the impact of biodegradable polymers on clinical events and stent thrombosis (ST) remains controversial.Methods We searched Medline,the Cochrane Library and other internet sources,without language or date restrictions for articles comparing clinical outcomes between biodegradable polymer DES and durable polymer DES.Safety endpoints were ST (definite,definite/probable),mortality,and myocardial infarction (MI).Efficacy endpoints were major adverse cardiac event (MACE) and target lesion revascularization (TLR).Results We identified 15 randomized controlled trials (n=17 068) with a weighted mean follow-up of 20.6 months.There was no statistical difference in the incidence of definite/probable ST between durable polymer-and biodegradable polymerDES; relative risk (RR) 0.83; 95% confidence interval (CI) 0.62-1.11; P=0.22.Biodegradable polymer DES had similar rates of definite ST (RR 0.94,95% CI 0.66-1.33,P=0.72),mortality (RR 0.94,95% C/0.82-1.09,P=0.43),MI (RR 1.08,95% CI 0.92-1.26.P=0.35),MACE (RR 0.99,95% CI 0.91-1.09,P=0.85),and TLR (RR,0.94,95% CI 0.83-1.06,P=0.30) compared with durable polymer DES.Based on the stratified analysis of the included trials,the treatment effect on definite ST was different at different follow-up times:≤1 year favoring durable polymer DES and 〉1 year favoring biodegradable polymer DES.Conclusions Biodegradable polymer DES has similar safety and efficacy for treating patients with coronary artery disease compared with durable polymer DES.Further data with longer term follow-up are warranted to confirm the potential benefits of biodegradable polymer DES.
基金This work was supported by the National Natural Science Fund for Young Scientists of China (Grant No. 51301049), the Fundamental Research Funds for the Central Universities (Grant No. HEUCF201310024), the National Natural Science Foundation of China (Grant No. 81271676), and the National High Technology Research and Development Program of China (863 Program Grant No. 2009AA03ZA23).
文摘A stent is a medical device designed to serve as a temporary or permanent internal scaffold to maintain or increase the lumen of a body conduit. The researcher;~ and engineers diverted to investigate biodegradable materials due to the limitation of metallic materials in stent application such as stent restenosis which requires prolonged anti platelet therapy, often result in smaller lumen after implantation and obstruct re-stenting treatments. Biomedical implants with temporary function for the vascular intervention are extensively studied in recent years. The rationale for biodegradable stent is to provide the support for the vessel in predicted period of time and then degrading into biocompatible constituent. The degradation of stent makes the re-stenting possible after several months and also ameliorates the vessel wall quality. The present article focuses on the biodegradable materials for the cardiovascular stent. The objective of this review is to describe the possible biodegradable materials for stent and their properties such as design criteria, degradation behavior, drawbacks and advantages with their recent clinical and preclinical trials.
文摘Biliary stricture is defined as the reduction and narrowing of the bile duct lumen, which can be caused by many factors such as cancer and inflammation. Biliary stent placement can effectively alleviate benign and malignant biliary strictures. However, the commonly used plastic or metallic biliary stents are far from ideal and do not satisfy all clinical requirements,although several types of biodegradable biliary stents have been developed and used clinically. In this review, we summarized current development status of biodegradable stents with the emphasis on the stent materials. We also presented the future development trends based on the published literature.