Implantation of SphinKeeperTM: a new artificial anal sphincter

Abstract

IntroductionA new artificial anal sphincter, SphinKeeperTM, was devised with the aim to treat fecal incontinence (FI) by implanting specifically designed self-expandable prostheses into the intersphincteric space. Preliminary data concerning the procedure feasibility and prosthesis localization at 3 months are presented.MethodsSphinKeeperTM prostheses in the native state are dehydrated, thin, solid cylinder (length 29 mm, diameter 3 mm), changing their state (shorter—length 23 mm, thicker—diameter 7 mm—and softer, with shape memory) within 48 h of contact with fluids. In this study, 10 prostheses were implanted in each patient with FI under local anesthesia and under endoanal ultrasound (EAUS) guidance, into the upper-middle intersphincteric space of the anal canal by a specifically designed delivery system. EAUS was used postoperatively to assess prostheses dislocation.ResultsTen patients (5 females; median age 58 years, range 20–75) were enrolled and treated with SphinKeeperTM implantation. Median duration of procedure (performed by endoanal ultrasound guidance) was 40 min (range 30–45). Neither intraoperative nor postoperative complications were reported after a 3-month follow-up. In one patient, a partial dislocation of a single prosthesis was documented by EAUS, causing anal discomfort which resolved after 1 week.ConclusionSphinKeeperTM can be safely implanted in patients with FI of different etiology. Implantation was well tolerated with no dislodgment of implants at 3-month follow-up.

Efficacy of Sphinkeeper™ implant in treating faecal incontinence

“…SK implantation was performed as described previously. Follow‐up visits were scheduled at 3, 6 and 12 months, and annually thereafter.…”

Anal Injectable and Implantable Bulking Agents for Faecal Incontinence

“…Publications on the Sphinkeeper are limited. Ratto et al [24] treated 10 patients with SK and followed them up for 3 months. The study demonstrated that the SK, with its larger prostheses than that of GK, is safe and effective.…”

“…When the injection is placed adjacent to an identifiable IAS defect, a better degree of anal canal sealing may be obtained through improvement in the configuration and symmetry of the anal canal [7]. Ratto argues that GK and SK, being embedded within the intersphincteric space, thereby pushing the EAS outwards and the IAS inwards, 'may improve sphincter contractility by increasing sarcomere length as well as increase the length of the anal canal and provide a powerful "bulking effect"' [24].…”

Artificial Muscle Devices: Innovations and Prospects for Fecal Incontinence Treatment

“…Devices, which require a partially functioning continence organ and reinforce the functionality of the sphincter muscles, are summarized together selected Refs. 8 , 9 , 36 , 48 , 49 in Table 1 . The sacral nerve stimulation (SNS) has become a standard operative procedure for the treatment of fecal incontinence.…”

“… Material (examples) Working principle Outcomes Relevance/Status Bulking agents (injected or implanted materials incl. SphinKeeper™) Collagen Autologous fat Silicone elastomers Teflon © Ceramic-microspheres Polyacryloniterile 48 , 49 Increases the volume around the anal canal, augment the passive closure pressure; self-expandable inter-sphincter prosthesis Success rates: 23–95% over a 3–19 month observational period 36 Success of placebo injections leads to success rates reaching 27% 36 Improvement in symptoms at least in the first year Small sample sizes and lack of long term studies do not permit general conclusions about safety and effectiveness 36 Slings (incl. FENIX ® ) Fascia Tendon Silk Nylon Teflon © Silicone Anal encirclement by bands.…”