REPORTED PROBLEM

Disconnection between
the valve and the filling
tube Leakage of the filling
solution through the pin
holes in the containment
cover

Simulation carried out in the Medicone laboratory

IMPORTANT INFORMATION

The containment cover is designed

with holes close to the region of
the valve system;

These holes aim to facilitate the

breaking of the cover during filling.
With this video we demonstrate
that when filling tube is
disconnected from the valve the
liquid leaks through the
containment cover instead of
filling the balloon. As the
containment cover has pin holes,
to facilitate the breaking of the
cover, the liquid spills through
these pin holes.
 With this video we demonstrate
the risk of leakage, premature
separation of the filling tube
and/or improper rupture of
containment cover when using a
syringes smaller than 50 cc volume
 INITIAL LEAKAGE IN PRACTICE
Silicone is a very heat sensitive material, so
improper storage or transport of the silicone can
alter the valve, causing it to close, which we call
a glue valve.
It may cause:
Difficulty in filling higher in the first syringes;
Small initial leak that soon ceases.

TIPS
• Care in the storage and transport;
• Put little liquid in the first syringes to "open" the valve;
• If the leak is small it is up to the doctor to decide whether to continue the filling to assess whether it
ceases, so it ends, makes the vacuum, disconnects the filling tube, washes the valve and observes that
there is no more leakage.
 HYPERINFLATION
The mechanism of spontaneous
hyperinflation of the intragastric
balloon is still unknown. The data
in the literature are scarce and do
not allow a conclusion. One
hypothesis is that there is some
relationship with infection by fungi
or anaerobic bacteria. However,
there is no plausible explanation
for this colonization.

OBSERVATIONS:
• Evidence indicates that some patients have a predisposition to present Hyperinflation, there are cases of
patients who put the balloon for more than 3x and in all cases presented hyperinflation...
• Usually happens on the middle to the end of treatment, but there is early hyperinflation.
CONTAINMENT COVER

The containment cover should

come out with the catheter. If this
does not happen it is important to
remove with the foreign body
tweezers or warn the patient that
he may expel this content later.
 OTHER POINTS OF ATTENTION
1. Leakage in the middle of treatment:
Muito raro, mas o azul de metileno é utilizado como marcado para que o paciente saiba se houver um
vazamento. Cuidado com as pastilhas que são colocadas no vazo para cheirinho....

2. Balloon "explode" at the time of drilling, at the withdrawal:

Staff should be careful, as the patient can aspirate the liquid. In addition, it may have been in small pieces
which makes it difficult to remove the balloon in full. Usually, it happens with balloon that are a little
hyperinflated.

3. Difference between the balloon of 6 and 12 months:

The silicone bath and the amount of layers is the big difference.
The right thickness to endure the 12 months but, do not get hard making it impossible to withdraw.

4. Stiffer balloon in retreat:

Due to the concentration of fungic colonies, the balloon becomes rigid, making it difficult to remove. Many
experienced doctors are overtube.

5. The Corporea/Conevita balloon is in its 3rd generation:

Each change provided significant improvements, more tied technology, and even stricter quality control.
 PRECAUTIONS AND SAFETY INFORMATION
DURING BALLOON PLACEMENT PROCEDURE
• Gently lubricate the retention cocoon with lindocaina gel without twisting the balloon or the extension tube;
• Never use syringes smaller than 50 cc volume;
• Faster pace of filling or syringes smaller than 50 cc will generate high pressure that could damage the valve balloon, causing
leakage, premature separation of the filling tube and / or improper rupture of containment cover;
• Patient must be positioned supine or left lateral;
• The balloon placement in incorrectly positioned pacients can generate stresses not expected in the product, causing a premature
disconnection of the filling tube;
• Keep the balloon aligned with the filling tube during placement (avoid angles greater than 30°);
• Product storage as specified:
• The balloon must be stored in a controlled environment. High temperatures (above 30°C) can cause a valve closure, preventing
filling and consequently causing leakage.
• Make sure there is a spare Intragastric Balloon for occasional complications during the procedure;

Check and read the instruction for use intragastric balloon for more details and information
 TECHNICAL TIPS

• If you have resistance at the beginning of the procedure, stop and check with the endoscope if the balloon
is bending in the patient's mouth;
• Better position the patient's head if you are having too much resistance to place the balloon;
• Always check balloon curvature searching for the right angle to insert the balloon and facilitate the
procedure;
• The patient's level of sedation may influence the level of difficulty or ease of the procedure;
• If you are experiencing too much resistance at the beginning of balloon placement, back off and seek one
of these tips to continue the procedure.
ATTENTION
 STORAGE

- Store at temperatures
between 15 ° and 30 ° C
- Protected from moisture and
light;
- Store in a dry place,
protected from the sun;
- Avoid high heat and
temperature.

Check and read the instruction for use intragastric balloon for more details and information
 MAIN STEPS: BALLOON PLACEMENT PROCEDURE
1. Patient must be positioned supine or left lateral;
2. Proceed to endevenose sedation or general anesthesia. Apply lidocaine spray oropharynx;
3. Perform gastroscopic verification of stomach, esophagus and duodenum to aspiration gastric contents in order to allow evidence of any
contraindication. Carry on procedure when absent any content;
4. Gently lubricate the retention cocoon with lindocaina gel without twisting the balloon or the extension tube;
5. Gently Insert Intragastric Balloon as far as the stomach;
6. Check the placement of the intragastric balloon with direct endoscopic visualization;
7. Remove the guide stainless steel wand slowly;
8. Connect a syringe with graduation of 50 or 60 cc with the extender;
9. Use to fill the intragastric balloon, saline with methylene blue in a ratio of 50:1
10. Use the punch extension tube for attachment to the saline bag;
11. Open communication between syringe and saline bag;
12. Fill the syringe with the pigmented saline. Remove air from the syringe to the purging effect for the intragastric balloon;
13. After removing the air from the system, connect the drive tube and the balloon filled extension tube;
14. Fill the flask with 50 cc at a time of slow manner so as not to damage the one-way valve;
15. Disconnect the extension tube of the steering tube and fill the intragastric balloon;
16. Connect the empty syringe directly from the conduction tube and fill the intragastric balloon;
17. Pull the syringe plunger slowly to form the vacuum check valve and ensuring the sealing of the intragastric balloon;
18. Still keeping the vacuum, gently pull the fill tube out of the patient, rotating clockwise;
19. Once disconnected the tube conduction and completion of intragastric balloon is no longer possible their re-connection;
20. Check that the containment membrane with the driving and filling tube;
21. Check for existence of one-way valve or leak in the intragastric balloon through direct endoscopic visualization. The finding leaks, the
intragastric balloon should be replaced immediately.

Check and read the instruction for use intragastric balloon for more details and information
 Obrigado!
THANK YOU!
Continuous development makes us who we are.
A Isofarma conquistou a liderança entre as indústrias nacionais na fabricação de soluções parenterais de pequeno
volume e medicamentos em sistema fechado. São 14 anos de dedicação e trabalho, que culminaram na integração à
A group that is proud of each product created,
gigante Halexistar, líder brasileira na categoria de soluções parenterais de grande volume.
capable of providing health and well-being to thousands of lives.