Fanelli Laparoscopic Endobiliary Stent Suggested Instructions for Use

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FanelliLaparoscopic Endobiliary StentSuggested
Instructions for Use

• Robert D. Fanelli, MD, FACS
• Assistant Professor of SurgeryUniversity of
  Massachusetts Medical SchoolDirector of Surgical
  EndoscopyBerkshire Medical Center

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Wire Guide Placement

• After performing fluorocholangiography, place
  wire guide through the central port of the
  cholangiogram catheter. Advance wire guide
  through common bile duct, across ampulla, and
  allow to coil gently in the duodenum.

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Catheter Removal

• The cholangiogram catheter is then removed over
  the wire guide, maintaining good wire position
  across the ampulla. Visual confirmation is
  achieved by maintaining the entire blue colored
  portion of the wire guide within the cystic duct.

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Dilate Cystic Duct

• The outer diameter of the stent system is 8.5
  French. Cystic duct dilation with a biliary
  dilation balloon is recommended if there is any
  concern that the cystic duct is too small to
  accommodate stent placement. About 30 of ducts
  required dilation in clinical studies.

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Stent Introduction

• Using fluoroscopic guidance, the stent system is
  introduced over the wire guide, through the
  common bile duct, and across the ampulla. The
  Tuohy-Borst valve is tightened during contrast
  injection to minimize leakage.

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Positioning

• After directing the stent across the ampulla over
  the wire guide, the stent is positioned so that
  markers 1 and 2 reside within the duodenum and
  markers 3 and 4 are within the common bile duct.
  Fluoroscopic imaging is essential to confirm
  proper positioning.

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Retracting Safety Sheath

• Remove the wire guide slowly, and recoil within
  the raceway in which it was shipped. Slowly
  retract the outer sheath, which securely attaches
  the stent to the delivery mechanism, back toward
  the purple and white Luer hubs, until it contacts
  the white hub.

Warning Once the outer sheath has been
retracted, it may not be possible to retrieve the
stent using the delivery mechanism.
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Stent Deployment

• Unscrew purple Luer connector from white Luer
  connector. Deploy stent by pulling white Luer and
  inner cannula completely out while holding the
  outer assembly still. Visualize deployment under
  fluoroscopy by watching radiopaque markers 1, 2,
  and 3 pull through the larger fourth marker.

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Assembly Removal

• Remove delivery assembly and proceed with
  laparoscopic cholecystectomy. Prior to assembly
  removal, a completion cholangiogram can be
  performed by injecting contrast through the
  assembly, if desired.

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Laparoscopic Endobiliary Stent

• Final placement