Research on Biomechanical Compatibility for the Artificial Anal Sphincter Based on Improved Actuator

Anal incontinence, also known as fecal incontinence, refers to the loss of the body's ability to accumulate and control the liquid, solid, and gas contents in the rectum, increasing the frequency of bowel movements. It is a symptom of defecation disorders. The artificial anal sphincter provides a new solution for clinical treatment. In this paper, in order to solve the problem of biomechanical compatibility of the actuator of the artificial anal sphincter system, the original actuator was improved. The model of the rectum and the actuator was constructed by ANSYS. The mechanical finite element analysis of the clamping mechanism was carried out by simulating sphincter behavior, and the displacement cloud diagram and stress cloud diagram of the clamping rectum were obtained. in vitro experiments were carried out using pig intestine to simulate the rectum, which verified the effectiveness of the actuator. The results of the experiment show that the successful rate of holding the rectum reached 96% under the condition of ensuring the normal blood supply to the rectum. It fully proves that the actuator has good biomechanical compatibility.

Assessment of a novel artificial anal sphincter with constant force

Fecal incontinence caused by sphincter dysfunction is an unresolved problem which has a serious effect on patients, both physically and psychologically. For patients with severe symptoms, treatment with an artificial anal sphincter could be a potential option to restore continence. Acticon Neosphincter still has safety and efficacy problems, which is the only device certified by the US Food and Drug Administration. The biomechanical compatibility is the key problem of artificial anal sphincter in the clinical application. This paper describes an artificial anal sphincter with superelastic shape memory alloys and its mechanical properties assessment in artificial intestine models. The new design was developed as a low invasive and constant force or pressure prosthesis with a simple structure to solve the problem of severe fecal incontinence in patients.

Inhibition of hyperplasia during the implantation of the puborectalis-like artificial anal sphincter

Objectives: 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. Method: 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%. Conclusion: 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.