Development of a new biodegradable operative clip made of a magnesium alloy: Evaluation of its safety and tolerability for canine cholecystectomy.
Operative clips used to ligate vessels in abdominal operation usually are made of titanium. They remain in the body permanently and form metallic artifacts in computed tomography images, which impair accurate diagnosis. Although biodegradable magnesium instruments have been developed in other fields, the physical properties necessary for operative clips differ from those of other instruments. We developed a biodegradable magnesium-zinc-calcium alloy clip with good biologic compatibility and enough clamping capability as an operative clip. In this study, we verified the safety and tolerability of this clip for use in canine cholecystectomy.



Nine female beagles were used. We performed cholecystectomy and ligated the cystic duct by magnesium alloy or titanium clips. The chronologic change of clips and artifact formation were compared at 1, 4, 12, 18, and 24 weeks postoperative by computed tomography. The animals were killed at the end of the observation period, and the clips were removed to evaluate their biodegradability. We also evaluated their effect on the living body by blood biochemistry data.



The magnesium alloy clip formed much fewer artifacts than the titanium clip, and it was almost absorbed at 6 months postoperative. There were no postoperative complications and no elevation of constituent elements such as magnesium, calcium, and zinc during the observation period in both groups.



The novel magnesium alloy clip demonstrated sufficient sealing capability for the cystic duct and proper biodegradability in canine models. The magnesium alloy clip revealed much fewer metallic artifacts in CT than the conventional titanium clip.
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Chuo-ku, Kobe, Hyogo, Japan.
Toshihiko
T
Yoshida
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Chuo-ku, Kobe, Hyogo, Japan. Electronic address: fukumoto@med.kobe-u.ac.jp.
Takumi
T
Fukumoto
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Chuo-ku, Kobe, Hyogo, Japan.
Takeshi
T
Urade
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Chuo-ku, Kobe, Hyogo, Japan.
Masahiro
M
Kido
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Chuo-ku, Kobe, Hyogo, Japan.
Hirochika
H
Toyama
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Chuo-ku, Kobe, Hyogo, Japan.
Sadaki
S
Asari
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Chuo-ku, Kobe, Hyogo, Japan.
Tetsuo
T
Ajiki
Department of Mechanical Engineering, Kobe University, Nada-ku, Kobe, Hyogo, Japan.
Naoko
N
Ikeo
Department of Mechanical Engineering, Kobe University, Nada-ku, Kobe, Hyogo, Japan.
Toshiji
T
Mukai
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Chuo-ku, Kobe, Hyogo, Japan.
Yonson
Y
Ku
D020341:Absorbable Implants; D000497:Alloys; D000818:Animals; D002763:Cholecystectomy / Q000295:instrumentation* / Q000379:methods; D004195:Disease Models, Animal; D004285:Dogs; D004869:Equipment Safety; D005260:Female; D007150:Immunohistochemistry; D008274:Magnesium / Q000737:chemistry*; D008422:Materials Testing; D011897:Random Allocation; D012680:Sensitivity and Specificity; D013525:Surgical Instruments
D000497:Alloys; D008274:Magnesium