Design and evaluation of an intelligent artificial anal sphincter system powered by an adaptive transcutaneous energy transfer system.

OBJECTIVES: The aim of this study was to optimize an intelligent artificial anal sphincter system (AASS) II for patients with severe fecal incontinence. METHODS: Redesigning and integrating a pressure sensor into the sphincter prosthesis allows us to reduce the sensor volume and makes it suitable for a chronic, ambulatory application. Furthermore, a close-loop frequency control method was designed for the transcutaneous energy transfer system. Finally, a longer working time of the implanted device was obtained by the low-power design of the hardware and software. The new model was implanted in 2 dogs and studied for periods of up to 5 weeks. RESULTS: The output voltage induced on the load of 30 Ω, for a variation range in k of 0.12 ~ 0.42, was maintained at approximately 6.8 V with a frequency control range of the 270 ~ 320 kHz. The minimum and maximum output voltages of the pressure sensor were found to be 1.7 V and 2.34 V, respectively, which corresponded to a pressure range of 90 ~ 120 kPa with maximum change rate of approximately 3.7% caused by the temperature variations. Moreover, compared with AASS I, the low-power design resulting in 94% reduction in power consumption. CONCLUSIONS: The efficacy of the device in achieving continence and sensing the need to defecate was assessed in an animal model. The technical concept and the design of the AASS II turned out to be capable of fulfilling the medical requirements.

Novel artificial anal sphincter system based on transcutaneous energy transmission system tested in vivo.

This paper proposes a novel artificial anal sphincter system (AASS) for severe fecal incontinence. The AASS is composed of an artificial anal sphincter (AAS), an external transcutaneous energy transmission system (TETS), and an external control device. The AAS is composed of a cuff, a micropump, a reservoir, and a remote control device. It is designed to be implanted into the body of the patient. The function of the AAS is to open and close the patient's natural anus. Patients suffering from loss of their natural sphincter lose rectal sensation and are thus unable to perceive imminent fecal incontinence. In order to restore rectal sensation, a pressure sensor in the AAS cuff is designed to detect pressure in the colon. The pressure reflects the present quantity of colon contents, allowing patients to control the AAS to open or close the anus according to the pressure. The TETS is designed to provide electrical energy to the implanted AAS without wire connections. The external control device is designed to receive the pressure information from the AAS and send the patient's command to the implanted device. This paper provides a thorough discussion of the design of the novel AASS and describes the performance of the AASS when tested in vivo on two Beagle dogs who were chosen to be the subjects for receiving the implant. The experimental results verified that the performance of the AASS met the functional requirements it was designed for; however, the trial also revealed some challenges to be further studied.