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4. Introduce the delivery catheter.
4.1 Perform ERCP if it has not already been done (Step 1)
and prepare the device by flushing with saline
solution (Step 3).
4.2 keeping the guide wire positioned through the
biliary stricture, remove any catheters. Make sure
to replace the positioned guide wire with a 0.035"
(0.89mm) guide wire if there is not one already
in place.
4.3 Holding the delivery catheter as straight as
possible, carefully insert the guide wire into the
tip of the delivery catheter.
4.4 Advance the delivery catheter over the guide wire
and through the endoscopic channel into the biliary
tract. Advance cautiously, especially if resistance
is encountered.
note: If significant resistance is met when advancing the
delivery catheter into the introducer sheath channel do
not torque the device. Remove and inspect the delivery
system for damage. Do not use if damaged.
note: In order to ensure precise stent placement,
radioscopic and endoscopic visualization of the stent
itself is necessary.
note: A sphincterotomy is not always essential for stent
delivery, but may be performed at the option of the
implanting physician.
5. deploy the stent as described below.
Important Guidelines for accurate Stent placement:
• Use the 5 radiopaque markers on the device as a
guide (figure 2 and figure 7) when positioning the
stent across the stricture. Radioscopic visualization is
required for accurate stent placement.
• Stent is located between radiopaque marker band
at distal end of the outer sheath and stent Stop
(figure 2). center the stent at the stricture (figure
7). Position the ends of the loaded stent at least
10-20mm proximal and distal to the margins of
the stricture.
• Remove the trigger safety connected at the second
trigger by pulling on the tab in the direction of the red
arrow and releasing the safety (Figure 8)
• To maintain stent placement, keep your elbow and
upper arm close to the side of your body. This will
keep the delivery handle still throughout stent
deployment.
• keep the delivery system as straight as possible
during stent deployment.
• Gently grab the stabilizing sheath at the entry into
the working channel of the endoscope and
immobilize it during deployment. this will ensure
placement accuracy. do not pinch or apply too
much force on stabilizing sheath as it will create
high deployment force and inaccurate stent
placement.
• A guide wire with radiopaque markers at known
intervals may also be used to assist in stent placement.
caUtIon: do NOT push forward on the delivery
system with the stent partially deployed. Pushing on
the delivery system may cause misalignment of the stent
and possible duct damage. The stent should deploy
easily. Do not deploy the stent if unusual force is required,
since this may indicate a device failure.
IMportant: While deploying the stent, maintain back
tension to prevent the device from creeping forward. This
action counters the tendency of the stricture to pull the
expanding stent forward.
note: The stent is not reconstrainable.
How to deploy the stent:
5.1 The delivery system has a handle with 2 deployment
triggers enabling the user to deploy the stent in 2
steps (Figure 8). Please ensure that the two
deployment triggers are approximately 2 inches
apart. If not, slide the first trigger (Figure 8) towards
the handle until you feel slight resistance.
5.2 Place the handle of the delivery system in the palm
of your hand (Figure 9). Wrap your ring and little
fingers around the base of the handle to form a 'pistol
grip. ' Then rest the tips of the index and middle fingers
on the first deployment trigger. Before you
start to deploy the stent, release the elevator of
the duodenoscope.
5.3 While visualizing under fluoroscopy, slowly pull back
the first deployment trigger until it touches the
handle. Confirm that the positioning of the stent
is correct.
5.4 If the stent is deployed more proximally than the
target location, it can be repositioned distally by
slowly applying traction to the handle while not
allowing the first trigger to move distally. Stop applying
traction once the stent is at the correct location.
5.5 When the first deployment trigger is touching the
handle, the stent will be deployed approximately
40-80% of its length (Figure 10).
5.6 After confirming the position of the stent, rest your
index and middle fingers on the second deployment
trigger (Figure 11).
5.7 Pull back the second deployment trigger until
the trigger touches the handle. The stent is now fully
deployed (Figure 12).
6. confirm stent deployment, then remove the
delivery system.
Confirm fluoroscopically that the stent has completely
deployed and expanded. Carefully remove the delivery
catheter from within the expanded stent without
disturbing the position of the stent. Continue to remove
the delivery catheter back over the guide wire.
7. confirm the patency and location of the stent,
using standard radiographic procedures.
8. remove all guide wires and catheters.
9. post-procedure management:
The patient should be observed for complications
associated with ERCP, biliary dilation and stent placement.
The patient should be monitored closely for 24 hours
post-implant. Patients should be routinely checked for
stent patency and location within 90 days of implant,
using standard radiographic procedures.
Implanting more than one stent:
Devices need to be overlapped by at least 1cm when more
than one device is placed to cover the stricture properly.
It is recommended that only devices of the same diameter
be overlapped. Even though the order of placement may
be dependent on the patient's anatomy and physician's
judgment, it is recommended that the device closest to
the liver is placed first. NOTE: Overlapping the stents more
than 1cm may compromise the patency of the lumen.
Mr conditional
Non-clinical
testing
has
demonstrated
ALIMaXX-B® Uncovered Biliary Stent is MR Conditional.
It can be scanned safely under the following conditions:
• Static magnetic field of 3-tesla or less
• Spatial gradient field of 720 Gauss/cm or less
• Maximum specific absorportion rate (SAR) of
3 W/kg for 15 minutes of scanning
In non-clinical testing, the ALIMaXX-B® Uncovered Biliary
Stent produced a temperature rise of less than or equal to
0.8˚C at a maximum specific absorportion rate (SAR) of 3
W/kg for 15 minutes of MR scanning in a 3-tesla MR system
using a transmit/receive body coil (Excite, Software G3.0-
052B, General Electric Healthcare, Milwaukee, WI) MR
scanner. MR image quality may be compromised if the
area of interest is in the exact same area or relatively close
to the position of the ALIMaXX-B®® Stent. Therefore, it
may be necessary to optimize MR imaging parameters for
the presence of this metallic implant.
StoraGe
Do not expose this device to conditions of extreme heat
and humidity. Store the MerIt endotek™ ALIMaXX-B®
Uncovered Biliary Stent System in a normal room
temperature environment.
Store in a cool, dry place.
How SUpplIed
The ALIMaXX-B® Uncovered Biliary Stent is supplied
SterIle by method of ethylene oxide. The ALIMaXX-B®
Uncovered Biliary Stent should not be re-sterilized.
Contact
MERIT
ENDOTEK™
1-800-35-MerIt (1-800-356-3748) if the package has
been opened or damaged.
The disposable, single-patient-use self-expanding stent
is available, pre-mounted on the delivery catheter in a
variety of configurations. The table below lists the lengths
and diameters of the currently available stents.
The recommended guideline for choosing stent length is
that the stent be long enough to extend 10-20mm past
both margins of the stricture.
table 1. Stent Sizes
Labeled Stent
Labeled Stent
Size (mm)
diameter x
length
8x40
8x60
8x80
10x40
10x60
10x80
All of the uncovered Biliary Stents are mounted on a
delivery catheter with a maximum outer diameter (OD) of
6.5F (2.2mm). The overall maximum length of the delivery
system is 217cm.
caUtIon: Federal law (USA) restricts this device to sale by
or on order of a physician.
Each packaged unit is intended for SInGle-patIent-USe
onlY.
For more information or to arrange for a demonstration,
contact MERIT ENDOTEK™ at the telephone number
shown on the previous page.
reUSe precaUtIon StateMent
Do not reuse, reprocess or resterilize. Reuse, reprocessing
or resterilization may compromise the structural integrity
of the device and/or lead to device failure which, in turn,
that
the
may result in patient injury, illness or death. Reuse,
reprocessing or resterilization may also create a risk
of contamination of the device and/or cause patient
infection or cross-infection, including, but not limited to,
the transmission of infectious disease(s) from one patient
to another. Contamination of the device may lead to
injury, illness or death of the patient.
Customer
Service
at
Flared Diameter
Diameter
of Both Stent
(mm)
Ends (mm)
8
10
10
12
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