Primary Puncture And Prosthesis Placement; Secondary Puncture And Prosthesis Placement - Atos Medical Provox Vega Instrucciones De Uso

2.2.1 Primary puncture and prosthesis placement

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1. After removal of the larynx and creation of the tracheostoma, before closure of the
pharynx, insert the Pharynx Protector in the open pharynx/esophagus (Fig. 2.1).
2. Verify the correct location for the TE puncture by palpating the inside of the trachea
at the desired puncture site. The oblique front opening of the Pharynx Protector (or
the slit on the upper side, depending on surgical technique) should be felt during
palpation (Fig. 2.2).
3. Insert the Puncture Needle at the correct puncture site (about 8-10 mm from the
edge of the tracheostoma) until the tip of the needle reaches the inner lumen of the
Pharynx Protector (Fig. 2.3).
If an endotracheal tube is in situ, this tube should be removed if it obstructs proper
dilatation and integral placement of the voice prosthesis.
4. Insert the Guidewire into the hub of the Puncture Needle. Push the Guidewire
through the needle until it extends approx. 20 cm out from the lumen of the Pharynx
Protector (Fig. 2.4).
WARNING: Always verify that the Guidewire comes out through the lumen of
the Pharynx Protector. Otherwise there is a risk for (sub) mucosal damage and the
procedure needs to be restarted (see Adverse Events and Troubleshooting Information
as well as Instructions for Reload of the Puncture Set).
5. Remove the Puncture Needle (Fig. 2.5).
CAUTION: Always remove the needle before removing the Pharynx Protector.
There is a risk for damaging the esophageal tissue otherwise.
6. Remove the Pharynx Protector. Only the Guidewire should remain in situ before
continuing (Fig. 2.6).
7. Insert the Guidewire extending from the esophageal side into the narrow end of
the Puncture Dilator and push the Guidewire through the Puncture Dilator until it
extends approx. 10 cm through the Puncture Dilator exit hole (Fig. 2.7).
8. Grab the tip of the Guidewire and insert it in the hole next to the exit hole (Fig. 2.8).
9. Tighten the Guidewire by pulling it from the narrow end of the Puncture Dilator and
verify that it is secured to the Puncture Dilator (Fig. 2.9).
10. Using a continuous, smooth motion; dilate the puncture site by carefully pulling
the Guidewire through the puncture. During dilatation, support the TE tissue (for
example with two fi ngers) to reduce dilatation force. For better control, fi rmly grasp
the Guidewire close to the Puncture Dilator (Fig. 2.10).
CAUTION: Dilatation and integral placement of the voice prosthesis should be
carried out in the anterior/caudal direction with limited lateral movement in order
to limit the force applied to the TE wall.
11. In the same continuous, smooth motion, carefully pull the Guidewire, Puncture
Dilator and the Puncture Dilator loop through the puncture. The Puncture Dilator
loop folds the tracheal fl ange of the voice prosthesis as the loop is pulled over the
fl ange and through the puncture. The tracheal fl ange unfolds in the trachea when the
loop releases it (Fig. 2.11).
Stop pulling immediately when the tracheal fl ange is released by the Puncture Dilator
loop. If the tracheal fl ange does not unfold completely, it can be rotated in place using
two non-toothed hemostats.
12. Grasp the tracheal fl ange of the voice prosthesis with a non-toothed hemostat, turn
the prosthesis in the correct position, and cut the safety strap (Fig. 2.12).

2.2.2 Secondary puncture and prosthesis placement

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The Pharynx Protector (Fig. 1.1) included in the Provox Vega Puncture Set is not used
during secondary puncture.
1. Choose an instrument (e.g., a rigid endoscope) which can function as;
a. a protector when the needle is penetrating the TE wall and
b. a guide for the correct location of the TE puncture and
c. a means to facilitate a safe passage of the Guidewire when it is passed through
the pharynx and out of the mouth.
Introduce the instrument into the esophagus (Fig. 3.1). If an endotracheal tube is
in situ, this tube should be removed if it obstructs proper dilatation and integral
placement of the voice prosthesis.
CAUTION: Always make sure that the instrument selected for pharynx protection
does contains a lumen for safe passage of the Guidewire. Otherwise, there is risk for
(sub) mucosal damage.
2. Verify the correct location of the instrument by palpating the trachea at the intended
puncture site. For additional visual and/or transilluminated guidance, a fl exible
endoscope could be used (Fig. 3.2).
3. Insert the Puncture Needle at the correct puncture site (about 8-10 mm from the
edge of the tracheostoma) until the tip of the needle reaches the inside wall of the
instrument (Fig. 3.3).
4. Insert the Guidewire into the hub of the Puncture Needle. Push the Guidewire into
the needle, up through the lumen of instrument until it extends approx. 20 cm out
through the distal end of the instrument (Fig. 3.4).
WARNING: Always verify that the Guidewire comes out through the lumen of
the instrument chosen for pharynx protection. Otherwise there is a risk for (sub)
mucosal damage and the procedure needs to be restarted (see Adverse Events and
Troubleshooting Information as well as Instructions for Reload of the Puncture Set).
5. Remove the Puncture Needle (Fig. 3.5).
CAUTION: Always remove the needle before removing the instrument. There is a
risk for damaging the esophageal tissue otherwise.
6. Remove the instrument used for pharynx protection. Only the Guidewire should
remain in situ before continuing (Fig. 3.6).
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