THD SphinKeeper® for faecal incontinence surgery - THDLAB - CO UK

  • THD SphinKeeper®: surgical equipment
  • THD SphinKeeper®: features and benefits

THD SphinKeeper®: surgical equipment

The THD SphinKeeper® surgical device consists of a Delivery System and 10 Dispensers which contain each the sterile self-expanding prostheses.

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

The Delivery System and Dispenser, in combination with the Portable EAUS Module enable verification of correct placement of the prosthesis without the need for additional equipment.

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THD SphinKeeper®: features and benefits

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

Delivery system

  • sterile
  • single patient use
  • 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, which allow growth 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 clinical evidence. No short- or long-term complications have been reported following the implanation1,2. 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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