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6. Remove the guidewire from the placement catheter.
7. Attach the sterile 50cc syringe to the Luer lock of the Fill
Kit's 3-way stopcock and then insert the spike of the Fill
Kit into a bag of sterile normal saline solution for injection
(.9 NS).
8. Slowly fill the IGB with sterile saline, 50cc at a time.
Repeat up to a minimum fill volume of 400cc to a
maximum fill volume of 700cc (14 strokes).
9. Gently remove the Placement Catheter and inspect the
IGB valve for leakage.
12.4 IGB REMOVAL (STEP-BY-STEP)
1. Ensure that the patient has been on a liquid diet for 72
hours and NPO (i.e. nothing by mouth) for a minimum of
12 hours before attempting removal. Whether this
regimen has been followed or not (i.e. in the case of an
urgent removal), due to the potential for residual gastric
contents in some patients, additional precautions for
aspiration should be considered. In higher risk patients
with signs and symptoms suggestive of severely
delayed gastric
obstruction, a focused physical examination for
abdominal distension and/or succussion splash should
be performed, followed by radiographic evaluation if
succussion splash is absent and the epigastrium is full
or tender. If radiographic evaluation is positive for
distended stomach with or without an antral IGB, then
nasogastric decompression should be considered, the
airway should be secured, and general anesthesia
employed.
2. Prepare the patient according to hospital protocol for
sedation and
administering a smooth muscle relaxant such as
intravenous glucagon to relax the esophageal sphincter.
3. Insert the endoscope into the patient's stomach.
4. Assess for the presence of food. If food is present in the
stomach the procedure should be delayed. If emergent
removal, the airway should be protected prior to
proceeding.
5. Get a clear view of the filled IGB using the endoscope.
6. Insert a sheathed needle catheter down the working
channel of the endoscope.
7. Use the advanced exposed needle to puncture the IGB.
8. Push the needle catheter through the IGB shell and well
into the IGB.
9. Remove the needle from the catheter.
10. Apply suction to the deeply inserted catheter until all
fluid is evacuated from the IGB.
11. Remove the catheter from the IGB and out of the
working channel of the endoscope.
12. Insert a long jaw or wire prong grasper through the
working channel of the endoscope.
13. Grab the IGB with the grasper (ideally at the opposite
end of valve if possible).
14. With a firm grasp on the IGB, slowly extract the IGB up
the esophagus.
15. When the IGB reaches the upper esophageal sphincter,
hyperextend the head to straighten the passage out of
emptying and/or gastric
endoscopy. Additionally,
the esophagus and throat, allowing for an easier
extraction.
16. Remove the IGB from the mouth.
12.5 IGB REPLACEMENT
If an IGB needs to be replaced, then follow the instructions
for IGB Removal and IGB Placement and Filling.
Additionally, it is recommended that the same volume of
sterile saline that was used during the placement of the
previous IGB (i.e. initial fill volume) be used when filling the
replacement IGB.
CAUTION: A larger initial fill volume in the replacement IGB
may result in severe nausea, vomiting or ulcer formation.
13. MEDICAL IMAGING
The saline filled IGB is considered to be MR Safe.
14. DISCLAIMER
OF REMEDY
There is no express or implied warranty, including without
limitation any implied warranty of merchantability or fitness
outlet
for a particular purpose, on the Apollo Endosurgery, Inc.
product(s) described in this publication. To the fullest extent
permitted by applicable law, Apollo Endosurgery, Inc.
disclaims all liability for any indirect, special, incidental, or
consequential damages, regardless of whether such liability
is based on contract, tort, negligence, strict liability, products
liability or otherwise. The sole and entire maximum liability
of Apollo Endosurgery, Inc., for any reason, and buyer's sole
and exclusive remedy for any cause whatsoever, shall be
limited to the amount paid by the customer for the particular
items purchased. No person has the authority to bind Apollo
Endosurgery, Inc. to any representation or warranty except
consider
as specifically set forth herein. Descriptions or specifications
in Apollo Endosurgery, Inc. printed matter, including this
publication, are meant solely to generally describe the
product at the time of manufacture and do not constitute any
express warranties or recommendations for use of the
product in specific circumstances. Apollo Endosurgery, Inc.
expressly disclaims any and all liability, including all liability
for any direct, indirect, special, incidental, or consequential
damages, resulting from reuse of the product.
1. Abu-Dayyeh B et al. A Randomized, Multi-Center Study
to Evaluate the Safety and Effectiveness of an Intragastric
Balloon As an Adjunct to a Behavioral Modification Program,
in Comparison With a Behavioral Modification Program
Alone in the Weight Management of Obese Subjects.
Gastrointestinal Endoscopy 2015: 81(5):AB147.
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OF WARRANTY AND
REFERENCES
LIMITATION