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Direct angioplasty, when it can be accomplished on a prompt basis
by experienced physicians at centers with catheterization laboratory
availability, should be considered a primary treatment option for patients
with acute myocardial infarction.
MATERIALS REQUIRED
Single Use, Sterile Items (Do not resterilize or reuse.)
•
Sterile heparinized normal saline
•
Guiding catheter (femoral or brachial) in the appropriate size and
configuration to select the coronary artery
•
Hemostatic valve(s)
•
60% contrast medium diluted 1:1 with normal saline
•
20 cc Luer-lock syringe (optional)
•
Appropriately sized guide wire (diameter not to exceed the maximum
guide wire for the dilatation catheter; see product label)
•
Guide wire introducer
•
Guide wire torque device
•
Inflation device
PREPARATION FOR USE
Prior to use examine all equipment carefully for defects. Examine the
dilatation catheter for bends, kinks, or other damage. Do not use any
defective equipment.
Prepare equipment to be used following manufacturer's instructions or
standard procedure.
Complete the following steps to prepare the TREK RX or MINI TREK RX
Coronary Dilatation Catheter for use:
1.
Remove the protective mandrel from the flushing sheath.
2.
Flush the TREK RX or MINI TREK RX Coronary Dilatation Catheter:
a)
Attach a syringe filled with heparinized normal saline to the
flushing hub, which is attached to the protective balloon sheath,
and inject heparinized saline into the lumen, or
b)
Attach a syringe filled with heparinized normal saline to the
flushing tool, insert the flushing tool into the distal end of the
catheter, and inject heparinized normal saline into the lumen.
Follow this procedure for subsequent flushing. Flush solution
should be seen coming out of the guide wire exit notch located
approximately 25 cm proximal to the balloon.
3.
Slide the protective sheath off the balloon.
Note: Submerge the balloon in sterile heparinized normal saline
during balloon preparation to activate the coating.
4.
Prepare an inflation device with the recommended contrast medium
according to the manufacturer's instructions.
5.
Evacuate air from the balloon segment using the following procedure:
a)
Fill a 20 cc syringe or the inflation device with approximately 4 cc
of the recommended contrast medium.
b)
After attaching the syringe or inflation device to the balloon
inflation lumen, orient the dilatation catheter with the distal tip
and the balloon pointing in a downward vertical position.
c)
Apply negative pressure and aspirate for 15 seconds. Slowly
release the pressure to neutral, allowing contrast to fill the shaft
of the dilatation catheter.
d)
Disconnect the syringe or inflation device from the inflation port of
the dilatation catheter.
e)
Remove all air from the syringe or inflation device barrel.
Reconnect the syringe or inflation device to the inflation port of
the dilatation catheter. Maintain negative pressure on the balloon
until air no longer returns to the device.
f)
Slowly release the device pressure to neutral.
g)
Disconnect the 20 cc syringe (if used) and connect the inflation
device to the inflation port of the dilatation catheter without
introducing air into the system.
CAUTION: All air must be removed from the balloon and
displaced with contrast prior to inserting into the body,
(repeat steps 5a through 5g, if necessary); otherwise,
complications may occur.
INSTRUCTIONS FOR USE
1.
Inser
t a guide wire through the hemostatic valve following the
manufacturer's instructions. Advance the guide wire carefully into and
through the guiding catheter. When complete, withdraw the guide wire
introducer, if used.
2.
Attach a torque device to the guide wire, if desired. Under fluoroscopy,
advance the guide wire to the desired vessel, then across the stenosis.
3.
Backload the distal tip of the dilatation catheter onto the guide wire
ensuring that the guide wire exits the notch located approximately
25 cm proximal to the balloon.
Note: When backloading the dilatation catheter onto the guide wire,
the dilatation catheter should be supported. In advancing the
dilatation catheter into the guiding catheter, one's hand should
support the dilatation catheter and firmly grasp the proximal shaft.
Shaft diameter differences should be taken into consideration when
opening and tightening the hemostatic valve and upon withdrawal of
the dilatation catheter.
4.
Advance the dilatation catheter over the guide wire until it approaches
the hemostatic valve. Open the hemostatic valve. Insert the dilatation
catheter while maintaining guide wire position and tighten the
hemostatic valve. To facilitate insertion, the balloon must be fully
deflated to negative pressure.
a)
Tighten the hemostatic valve to create a seal around the dilatation
catheter without inhibiting movement of the dilatation catheter. This
will allow continuous recording of proximal coronary artery pressure.
Note: It is important that the hemostatic valve be closed tightly
enough to prevent blood leakage around the dilatation catheter
shaft, yet not so tight that it restricts the flow of contrast into and
out of the balloon or restricts guide wire movement.
b)
Advance the dilatation catheter until the appropriate proximal
marker aligns with the hemostatic valve hub. This indicates that
the dilatation catheter tip has reached the guiding catheter tip.
5.
Advance the dilatation catheter over the guide wire and into the
stenosis or stent. Inflate the balloon to a very low pressure (1 atm, 1
bar or 15 psi) to confirm that the balloon is correctly positioned.
Note: When using the dual wire technique, a DUOSTAT (or equivalent)
dual hemostatic valve should be used and care taken when
introducing, torquing, and removing one or both wires to avoid
entanglement. Guide wires should not be rotated more than
180 degrees in either direction during the dual wire procedure. It is
recommended that one wire be completely withdrawn from the
patient before removing additional equipment.
6.
Inflate the balloon (not to exceed 10 total inflations in a stent or
20 total inflations without a stent) to perform PTCA or postimplant
dilatation of a stent per standard procedure. Maintain negative
pressure on the balloon between inflations.
7.
Withdraw the deflated dilatation catheter and guide wire from the guiding
catheter through the hemostatic valve. Tighten the hemostatic valve.
Note: After the deflated balloon dilatation catheter is withdrawn, it
should be wiped clean with gauze soaked with sterile, heparinized
normal saline and stored. Prior to reinsertion, the balloon should be
submerged in sterile, heparinized normal saline to reactivate the
coating.
8.
Coil the dilatation catheter using the clip as follows:
a)
The dilatation catheter may be coiled once using the clip provided
in the package. See diagram below for proper dilatation catheter
coiling and clip placement.
b)
Care should be taken not to kink or bend the shaft upon
placement or removal of the clip. Only the proximal shaft should
be secured with the dilatation catheter clip; it is not intended for
the distal end of the dilatation catheter.
Proper Dilatation Catheter Coiling
Before
Proper Dilatation Catheter Clip Placement
After
EXCHANGE PROCEDURE TECHNIQUE
The TREK RX and MINI TREK RX Coronary Dilatation Catheters have been
specifically designed for rapid, single operator balloon exchanges. To
perform a dilatation catheter exchange:
1.
Loosen the hemostatic valve.
2.
Hold the guide wire and hemostatic valve in one hand, while grasping
the balloon shaft in the other hand.
3.
Maintain guide wire position in the coronary artery by holding the wire
stationary, and begin pulling the dilatation catheter out of the guiding
catheter while monitoring the wire position under fluoroscopy.
4.
Withdraw the deflated dilatation catheter until the notch in the guide
wire lumen is reached (marker indicates notch). Carefully inch the
flexible, distal portion of the dilatation catheter out of the rotating
hemostatic valve while maintaining the guide wire's position across
the lesion.
5.
Slide the distal tip of the dilatation catheter out of the hemostatic
valve, and tighten onto the guide wire to hold it securely in place.
Completely remove the dilatation catheter from the guide wire.
6.
Prepare the next dilatation catheter to be used, as previously
described in the Preparation for Use section.
7.
Backload another dilatation catheter onto the guide wire as previously
described under the Instructions for Use section, step 3, and
continue the procedure accordingly.
REFERENCES
The physician should consult recent literature on current medical practice
on balloon dilatation, such as that published by the American College of
Cardiology and the American Heart Association.
PATENTS AND TRADEMARKS
This product and its use are protected by one or more of the following
patents: United States 5,242,396; 5,451,233; 5,480,383; 5,496,275;
5,525,388; 5,533,968; 5,554,121; 5,902,290; 5,993,460; 6,013,054;
6,013,069; 6,059,748; 6,129,707; 6,139,525; 6,156,047; 6,165,152;
6,179,810; 6,193,686; 6,200,325; 6,206,852; 6,217,547; 6,221,425;
6,224,803; 6,238,376; 6,251,094; 6,368,301; 6,488,688; 6,572,813;
6,579,484; 6,589,207; 6,835,059; 7,273,487; 7,662,130. Other U.S.
patents pending. Foreign patents issued and pending.
DUOSTAT, TREK, and MINI TREK are trademarks of the Abbott Group of
Companies.
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