THD SphinKeeper® for faecal incontinence surgery - THDLAB - COM

  • THD SphinKeeper®: surgical device
  • THD SphinKeeper®: features and advantages

THD SphinKeeper®: surgical device

The THD SphinKeeper® surgical device consists of an implant system called Delivery System and of 10 Dispensers containing an equal number of self-expanding sterile prostheses.

Each dispenser is equipped with a cannula for inserting the prostheses in the intersphincteric space. The THD SphinKeeper® sterile prostheses are inserted between the internal and external anal sphincter by means of the specific Delivery System.

Delivery System and Dispenser, in combination with the EAUS Module for verifying the correct positioning of the prosthesis, allows for performing the surgical procedure THD Sphinkeeper® without the need for additional equipment.

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THD SphinKeeper®: features and advantages

All components of the THD SphinKeeper® device are designed with the highest quality standards to ensure the highest level of comfort and safety for the surgeon and patient and to reduce the risk of infections and surgical complications.

  • Delivery system
    • sterile
    • single patient
    • ergonomic handle
    • practical LED indicators to guide the different surgical phases
  • Dispenser
    • sterile
    • single-use
  • Self-expanding prostheses
    • sterile (supplied inside the dispensers)
    • biocompatible
    • non-allergenic
    • non-carcinogenic
    • non-degradable
    • non-pyrogenic
    • non-immunogenic
    • biologically inert

The implants are made of a self-expanding material equipped with a shape memory, able to grow in volume through the absorption of body fluids.

Within 48 hours of implantation, the prostheses expand by absorbing the physiological fluids and increase their volume up to 730% of their original size. Thanks to the "shape memory" effect, the prostheses return to their initial shape following the movement of the anal sphincters.

The efficacy and safety of THD SphinKeeper® is supported by an ample clinical evidence. No short- or long-term complications have been reported following the implant1,2. The rare cases of implant migration have been easily resolved and have not compromised the effectiveness of the results.2

Bibliography:

  1. Efficacy of SphinKeeper implantation in faecal incontinence patients: 1-year experience. L. Donisi, A. Parello, F. Litta & C. Ratto, Colorectal Disease, Volume 18, Supplement 1, P409, September 2016
  2. Implantation of SphinKeeperTM: a new artificial anal sphincter. C. Ratto, L. Donisi, F. Litta, P. Campennì, A. Parello. Tech Coloproctol (2016) 20: 59-66.
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