All about CoreFlow – Soft Stent

Sonny Schelin shows CoreFlow – Soft Stent

Intended use

User Manual, CoreFlow Soft Stent_English

Information to patient, English

CoreFlow®– Soft Stent is a device intended to be used to temporarily resolve obstruction of the prostatic urethra.

  • Enables sphincter-controlled continence and is suitable for patients with urinary retention.
  • Temporarily de-obstructs the prostatic urethra.
  • Two-piece innovative design simplifies the introduction and allows initial use as a normal indwelling catheter.
  • Designed with a balloon at its proximal end for bladder anchor and coil in the distal section to keep it from migrating.

CoreFlow® – Soft Stent is a catheter with two functions:

  • Can empty the bladder like a normal indwelling catheter (CAD)
  • When the rear section is removed, the front section functions as a short catheter for the prostatic urethra. The micturition functions normally and the external sphincter is closed after micturition.

CoreFlow® – Soft Stent-principle:
CoreFlow® is a soft stent consisting of two parts, one front and one rear section, see figure 1. The two sections can be separated by a simple operation.

  • The diameter of the front section is 20 Fr /6.7mm and the rear section is 16 Fr / 5.3 mm.
  • CoreFlow®– Soft Stent has a drainage lumen as well as a balloon at its proximal (inner) end to anchor it in the bladder.
  • The separation of CoreFlow® – Soft Stent occurs 40 or 50 mm (depending on the selected stent length) below the anchoring balloon.
  • The balloon is filled with sterile water using a medical syringe connected with a luer taper to the balloon inflation valve.
  • A catheter connector with or without a urinary bag can be attached to the drainage funnel.
  • The balloon inflation tube forms a spiral 25 mm below the front section. The spiral has the function of a second anchor and prevents CoreFlow® – Soft Stent from sliding up into the bladder.
  • A thread is attached to the front section and runs through the drainage lumen. When the front and rear sections of Coreflow® – Soft Stent are connected the two sections are held together with this thread. The thread is covered by a silicone layer on the funnel part to prevent leakage.
  • CoreFlow® – Soft Stent may only be used for a maximum of 29 days.
  • CoreFlow®– Soft Stent is delivered sterile and ready for use.
INTENDED USETemporarily de-obstructs the prostatic urethra.

INTENDED USER PROFILEMale patients with urinary retention. Stent length 40 mm for prostate length >40 mm (volumes 25 – 50 cc). Stent length 50 mm for prostate length >50 mm (volumes >50 cc).
INTENDED USE ENVIRONMENTHospitals, health care centers and home environment.