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Development of an implantable artificial anal sphincter using a shape memory alloy
Kotaro Nishi1, Takamichi Kamiyama, Motoshi Wada
1Department of Pediatric Surgery, Graduate School of Medicine, Japan.
Journal of Pediatric Surgery
|December 25, 2003
Summary
A novel artificial anal sphincter using shape memory alloy (AS-SMA) effectively restored fecal continence in piglets. This device shows promise as a substitute for impaired anal sphincters with manageable side effects.
Area of Science:
- Biomedical Engineering
- Materials Science
Background:
- Fecal incontinence significantly impacts quality of life.
- Current treatments for fecal incontinence have limitations.
Purpose of the Study:
- To develop and evaluate a new artificial anal sphincter (AS-SMA) for treating fecal incontinence.
- To assess the efficacy and safety of AS-SMA in a preclinical model.
Main Methods:
- The AS-SMA device, composed of Ti-Ni plates, was applied to a piglet's colostomy.
- The device generated 55 mm Hg pressure at rest and formed an almond shape upon electrical stimulation.
- The device was operated for one month, monitoring fecal continence, bowel movements, and animal condition.
Main Results:
- Fecal continence was achieved when the AS-SMA was in its resting position.
- Bowel movements were successfully induced upon device operation (78% success rate).
- The device demonstrated a good safety profile with mild inflammation and no compression injury observed.
Conclusions:
- The AS-SMA effectively achieved fecal continence in a preclinical model.
- The device presents a potential alternative to impaired anal sphincters.
- Further reduction of side effects could enhance its clinical applicability.