Warning: Prior to use read all package inserts warnings, precautions, and instructions. Safety and efficacy Considerations: Do not use if package has been previously opened or damaged. Failure to do so may result in severe patient injury or death. The product is designed for single use only. Do not resterilize or reuse. Do not alter the Multiple Instrument Guide (MIG) instrument, or any of the kit/set components during insertion, use, or removal.
WARNING:
This device should only be used by a physician thoroughly trained in the technique of laparoscopic cholecystectomy and laparoscopic common bile duct exploration (LCBDE). The MIG should be inserted and manipulated only under laparoscopic visualization. Practitioners must be aware of complications associated with common bile duct exploration and stone removal including contrast reactions, injury to the common bile duct or other organs, pancreatitis, bleeding, infection, or visceral perforation.
Indications for Use:
The Multiple Instrument Guide (MIG) is used for surgical instrument and choledochoscope access into the common bile duct during laparoscopic common bile duct exploration (LCBDE).
SUGGESTED PROCEDURE:
Use sterile technique.
1. Perform operative cholangiogram.
2. Identify the common bile duct
3. Perform anterior longitudinal (7–12mm) choledochotomy.
4. Wet the purple MIG inside and out with sterile saline to activate hydrophilic lubricious coating (for friction reduction).
5. Insert 2.8mm choledochoscope into 3.4mm MIG channel. Note: curvature of choledochoscope tip should parallel the curvature of the MIG’s tip.
6. Insert 4F balloon catheter and 4F or 5F irrigation catheter into the two smaller MIG channels, otherwise insert the white occlusion plug into one or both of the smaller MIG channels.
7. Pull the curved tip of the MIG into the transparent introducer sheath.
8. Insert the introducer sheath and MIG with associated choledochoscope and catheters through a 10mm laparoscopic port positioned above the choledochotomy.
9. Advance the MIG through the introducer sheath, and it will reassume the curved tip configuration.
10. Advance the MIG tip into choledochotomy.
11. Start irrigation through irrigation catheter to distend the CBD.
12. Advance the video choledochoscope into the CBD to identify anatomy and pathology.
13.
Use video choledochoscope to guide application of
balloon catheter, irrigation catheter, stone basket, biopsy forceps and/or
electrohydraulic lithotriptor to dislodge and/or destroy CBD stones for
removal. Use of instruments and
combinations of instruments is at the discretion of the laparoscopic surgeon,
based on the particulars of each case. Note The lithotriptor is best deployed through the
working channel of the choledochoscope, with an irrigation catheter deployed in
adjacent MIG lumen. Caution: lithotriptor must be in direct contact with stone. Contact with the wall of the bile duct may
lead to perforation or injury.
14. Choledochoscope and catheters may be withdrawn into the MIG, and the MIG rotated 180 degrees to inspect proximal hepatic ducts.
15. Choledochoscope and catheters are withdrawn into the MIG, and the MIG is withdrawn into the sheath during removal (or insertion) of apparatus.
16. After completion of the LCBDE, a T tube is placed, along with a closed suction drain, particularly when cholangitis or distal bile duct obstruction, or edema is present.
EQUIPMENT REQUIREMENTS FOR LCBDE USING MIG
-Laparoscopic video
system with dual cameras and picture in a picture capability
-Laparoscopic port
set for laparoscopic cholecystectomy
-Complete set advanced
laparoscopic instrumentation
-2.8 or 3.2mm
flexible choledochoscope
-4Fr. or 5Fr.
Balloon and irrigation catheters
-1.7 Fr. O.D. electrohydraulic lithotriptor probe
-Assorted stone
baskets 4Fr. or 5Fr.
-T-tube
MULTIPLE INSTRUMENT GUIDE (MIG), purple
SHEATH, transparent
DUAL PRONGED PLUG, white