Novel zinc alloys for biodegradable surgical staples  

作　　者：Hizuru Amano Koichi Miyake Akinari Hinoki Kazuki Yokota Fumie Kinoshita Atsuko Nakazawa Yujiro Tanaka Yasuhiro Seto Hiroo Uchida 

机构地区：[1]Department of Pediatric Surgery,Graduate School of Medicine,The University of Tokyo,Tokyo 113-8655,Japan [2]Mitsui Mining and Smelting Co.,Ltd.,Tokyo 141-0032,Japan [3]Department of Pediatric Surgery,Nagoya University Graduate School of Medicine,Nagoya 466-8550,Japan [4]Department of Advanced Medicine,Nagoya University Hospital,Nagoya 466-8560,Japan [5]Department of Clinical Research,Saitama Children’s Medical Center,Saitama 330-8777,Japan

出　　处：《World Journal of Clinical Cases》2020年第3期504-516,共13页世界临床病例杂志

摘　　要：BACKGROUND The development of biodegradable surgical staples is desirable as non-biodegradable Ti alloy staples reside in the human body long after wound healing, which can cause allergic/foreign-body reactions, adhesion, or other adverse effects. In order to develop a biodegradable alloy suitable for the fabrication of surgical staples, we hypothesized that Zn, a known biodegradable metal, could be alloyed with various elements to improve the mechanical properties while retaining biodegradability and biocompatibility. Considering their biocompatibility, Mg, Ca, Mn, and Cu were selected as candidate alloying elements, alongside Ti, the main material of clinically available surgical staples.AIM To investigate the in vitro mechanical properties and degradation behavior and in vivo safety and feasibility of biodegradable Zn alloy staples.METHODS Tensile and bending tests were conducted to evaluate the mechanical properties of binary Zn alloys with 0.1–6 wt.% Mg, Ca, Mn, Cu, or Ti. Based on the results,three promising Zn alloy compositions were devised for staple applications(wt.%): Zn-1.0Cu-0.2Mn-0.1Ti(Zn alloy 1), Zn-1.0Mn-0.1Ti(Zn alloy 2), and Zn-1.0Cu-0.1Ti(Zn alloy 3). Immersion tests were performed at 37℃ for 4 wk using fed-state simulated intestinal fluid(Fe SSIF) and Hank’s balanced salt solution(HBSS). The corrosion rate was estimated from the weight loss of staples during immersion. Nine rabbits were subjected to gastric resection using each Zn alloy staple, and a clinically available Ti staple was used for another group of nine rabbits. Three in each group were sacrificed at 1, 4, and 12 wk post-operation.RESULTS Additions of ≤1 wt.% Mn or Cu and 0.1 wt.% Ti improved the yield strength without excessive deterioration of elongation or bendability. Immersion tests revealed no gas evolution or staple fracture in any of the Zn alloy staples. The corrosion rates of Zn alloy staples 1, 2, and 3 were 0.02 mm/year in HBSS and 0.12, 0.11, and 0.13 mm/year, respectively, in Fe SSIF. These degradation times BACKGROUND The development of biodegradable surgical staples is desirable as non-biodegradable Ti alloy staples reside in the human body long after wound healing, which can cause allergic/foreign-body reactions, adhesion, or other adverse effects. In order to develop a biodegradable alloy suitable for the fabrication of surgical staples, we hypothesized that Zn, a known biodegradable metal, could be alloyed with various elements to improve the mechanical properties while retaining biodegradability and biocompatibility. Considering their biocompatibility, Mg, Ca, Mn, and Cu were selected as candidate alloying elements, alongside Ti, the main material of clinically available surgical staples.AIM To investigate the in vitro mechanical properties and degradation behavior and in vivo safety and feasibility of biodegradable Zn alloy staples.METHODS Tensile and bending tests were conducted to evaluate the mechanical properties of binary Zn alloys with 0.1–6 wt.% Mg, Ca, Mn, Cu, or Ti. Based on the results,three promising Zn alloy compositions were devised for staple applications(wt.%): Zn-1.0Cu-0.2Mn-0.1Ti(Zn alloy 1), Zn-1.0Mn-0.1Ti(Zn alloy 2), and Zn-1.0Cu-0.1Ti(Zn alloy 3). Immersion tests were performed at 37℃ for 4 wk using fed-state simulated intestinal fluid(Fe SSIF) and Hank’s balanced salt solution(HBSS). The corrosion rate was estimated from the weight loss of staples during immersion. Nine rabbits were subjected to gastric resection using each Zn alloy staple, and a clinically available Ti staple was used for another group of nine rabbits. Three in each group were sacrificed at 1, 4, and 12 wk post-operation.RESULTS Additions of ≤1 wt.% Mn or Cu and 0.1 wt.% Ti improved the yield strength without excessive deterioration of elongation or bendability. Immersion tests revealed no gas evolution or staple fracture in any of the Zn alloy staples. The corrosion rates of Zn alloy staples 1, 2, and 3 were 0.02 mm/year in HBSS and 0.12, 0.11, and 0.13 mm/year, respectively, in Fe SSIF. These degradation times

关 键 词：Zinc alloy Surgical staple Gastric resection Biodegradability Biocompatibility Mechanical Strength 

分 类 号：R318.08[医药卫生—生物医学工程]