14.Pass the tunneler (A) and catheter (B)
subcutaneously from the second incision up to
and out through the first incision at the guidewire
insertion site. (Figure 4) Continue to draw the
catheter through the tunnel until the polyester
cuff lies inside the tunnel, about 1 cm (C) from
the second incision. (Figure 5). Disconnect the
tunneler from the catheter.
Note: If the cuff is advanced further into the tunnel,
it can make later removal of the catheter difficult.
15.Thread the 16 Fr peel-away introducer sheath
over the guidewire into the pleural cavity.
16.Remove the guidewire and dilator as a unit,
leaving the 16 Fr peel-away introducer sheath in
place.
Caution: Place a thumb over the end of the sheath
as the dilator is removed to avoid air entering the
pleural cavity. Care must be taken not to bend or
kink the sheath. Damage to the sheath may prevent
passage of the catheter.
17.Insert the fenestrated end of the catheter into the
sheath advancing it until all the fenestrations are
within the pleural cavity. This can be verified
under fluoroscopy as fenestrations are located
along the barium sulfate stripe.
18.Peel away the sheath while ensuring the catheter
remains in place. Adjust the catheter so that it
lies flat in the tunnel without any kinks.
Caution: Do not use forceps on the introducer to
break the handle and/or peel the sheath.
19.Close the incision at the guidewire insertion site.
20.Close the incision site around the catheter and
suture the catheter to the skin taking care not to
restrict the diameter of the catheter. This suture
is intended to remain in place at least until there
is tissue ingrowth around the cuff.
Caution: Exercise care when placing ligatures to
avoid cutting or occluding the catheter.
Note: After suturing, Dermabond™ Topical Skin
Adhesive (not included) may be applied topically
over the guidewire insertion site and catheter exit
site. This may aid in preventing leakage by assisting
in wound closure. Follow the instructions for use
provided by the manufacturer.
Drainage Procedure
The drainage procedure can be performed using:
a) PleurX™ Vacuum Bottle(s)
b) Lockable Drainage Line with glass vacuum
bottle(s) or with wall suction.
If using PleurX™ Vacuum Bottle(s), refer to PleurX™
Drainage Kit Instructions for Use to perform the
drainage procedure.
Caution: Re-expansion pulmonary edema may occur
if too much fluid is removed too rapidly. Therefore, it
is recommended to limit the initial drainage to no
more than 1,500 ml. The volume of pleural fluid
removed should be based on the patient's individual
status.
Caution: Potential complications of access and
drainage of the pleural cavity include, but may not
be limited to, the following: re-expansion pulmonary
edema, pneumothorax, laceration of the lung or
liver, hypotension/circulatory collapse, wound
infection, empyema and infection in the pleural
cavity.
Connect the Drainage Line to Wall Suction
Caution: Keep the valve on the PleurX™ Catheter
and the lockable access tip on the drainage line
clean. Keep them away from other objects to help
avoid contamination.
Caution: If wall suction or portable suction is used,
it must be regulated to no greater than -60 cm H
or to drain no more than 400 ml of fluid per minute.
(-60 cm H
O = -1.7 in Hg = -44 mm Hg = -0.8 psi)
2
Make sure that the portable suction unit is capable
of regulating to -60 cm H
suction unit instructions for use prior to draining.
1. Close the roller clamp completely by rolling the
wheel on the roller clamp toward the suction
source. (Figure 6)
Caution: The roller clamp must be fully closed to
occlude the drainage line. When not connected to a
suction source, make sure the roller clamp is fully
closed; otherwise the drainage line may allow air
into the body or let fluid leak out.
2. Attach the 5-in-1 adapter to the Luer fitting on
the drainage line.
3. Connect the 5-in-1 adapter to the suction source.
4. Remove the cover with the lockable access tip by
twisting it and pulling gently. Discard the cover.
(Figure 7)
5. Insert the lockable access tip on the drainage line
securely into the catheter valve. You will feel and
hear a click when the lockable access tip and
valve are securely connected. (Figure 8)
6. If desired, lock the access tip to the catheter
valve by twisting the access tip until you feel and
hear a second click. (Figure 9)
Caution: Make sure that the valve and the lockable
access tip are securely connected when draining. If
they are accidentally separated, they may become
contaminated. If this occurs, clean the valve with an
alcohol pad and use a new drainage line to avoid
potential contamination.
Caution: Precautions should be taken to ensure the
drainage line is not tugged or pulled.
Connect the Drainage Line to Glass Vacuum
Bottle(s)
Caution: Keep the valve on the catheter and the
lockable access tip on the drainage line clean. Keep
them away from other objects to help avoid
contamination.
Caution: When draining with glass vacuum bottles,
do not use a needle larger than 17 G.
1. Close the roller clamp completely by rolling the
wheel on the roller clamp toward the glass
vacuum bottle. (Figure 6)
3
O,
2
O or less. Check portable
2