OBJECTIVE: This study aims to extend the implantation lifetime of the puborectalis-like artificial anal sphincter by inhibiting the occurrence of hyperplasia following the implantation process.
METHODS: A new transmission structure was designed inside the puborectalis-like artificial anal sphincter to generate an adequate torque to maintain the feces, even if hyperplasia developed around the prosthetic sphincter. An outer shell was added to the prosthetic sphincter to decelerate the occurrence of hyperplasia on the outer shell side. Medical titanium alloy was tested to replace the nylon-12 prosthetic sphincter, while polyetheretherketone was used for the construction of the power supply unit in the puborectalis-like artificial anal sphincter system instead of nylon-12. In vivo experiments were conducted to evaluate all the methods presented in this study with 10 Pa Ma piglets, 1 domestic pig, and 1 beagle dog during the past 2 years.
RESULTS: Compared with the previous prosthetic sphincter that was equipped with a fixed-axle gear transmission, the new transmission structure is equipped with a planet-gear train managed to generate a prosthetic sphincter output with a 53% larger torque but with the same size and type of motor as that used previously and increase the implantation lifetime by 56%. After the replacement of the nylon-12, the new prosthetic sphincter made of medical titanium alloy succeeded in extending the implanted lifetime by 83%. In addition, the lifetime was increased by 143%, when an outer shell was added to the prosthetic sphincter. Polyetheretherketone significantly decreased the growth rate of hyperplasia around the power supply unit by 44% after the replacement of the power supply unit material. After the combination of all the improvements, the longest implantation lifetime of the puborectalis-like artificial anal sphincter during the in vivo experiments was 7 months and 10 days, which reflected an improvement of 249%.
CONCLUSIONS: All methods posted in this study were evaluated to be effective to prolong the implantation lifetime of the puborectalis-like artificial anal sphincter. Among the methods proposed, the most effective was the addition of the outer shell to the puborectalis-like artificial anal sphincter. The least effective method was the improvement of the transmission structure. Medical titanium alloy and polyetheretherketone were good replacements for nylon-12 that managed to extend the implantation lifetime and yield a moderate improvement.