Abiomed Impella 2.5, Инструкция по эксплуатации

Страница: 80 / 211

5.26 Instructions for Use & Clinical Reference Manual (US)
3. To prepare the repositioning sheath, remove the luer plug at the end of the sidearm
tube and flush the tube with 0.9% NaCl solution.
Place the luer plug back in the sidearm tube and secure the plug.
4.
Make the incision as close as possible to the distal loop. Insert a diagnostic catheter
(Abiomed recommends a 6 Fr AL1 or Multipurpose without side holes or 4–5 Fr pigtail
with or without side holes) over a diagnostic 0.035 inch or 0.038 inch guidewire into
the left ventricle.
5.
Remove the diagnostic guidewire and exchange it for the supplied 0.018 inch
placement guidewire.
6.
Hold tension on the proximal vessel loop to prevent bleeding. Straighten the blue
pigtail and thread it over the 0.018 inch placement guidewire (see Figure 5.31). Wet the
cannula with sterile water and backload the catheter onto the placement guidewire.
One or two people can load the catheter on the guidewire.
Catheter (with marking) Outlet Sensor
Inlet Guidewire Pigtail
1cm
Figure 5.31 Guidewire Placement
One-person technique
a. Advance the placement guidewire into the Impella
®
5.0 Catheter and stabilize
the cannula between the fingers. This prevents pinching of the inlet area. The
placement guidewire must exit the outlet area on the inner radius of the cannula
as shown in Figure 5.31, and align with the straight black line on the catheter. The
catheter can be hyperextended as necessary to ensure the placement guidewire
exits on the inner radius of the cannula.
Two-person technique
b.
The scrub assistant can help stabilize the catheter by holding the catheter proximal
to the motor. This will allow the implanting physician to visualize the inner radius.
The placement guidewire must exit the outlet area on the inner radius of the
catheter and align with the straight black line on the catheter. The physician can
focus on advancing the placement guidewire and, if the cannula needs to be
hyperextended, the scrub assistant is available to assist.
7. Make a transverse incision at the guidewire for the 21 Fr catheter. Use U-stitches
(see Figure 5.30) instead of purse string sutures to avoid stenosis of the vessel after
explantation.
8.
Administer heparin and achieve ACT of at least 250 seconds.
9. Insert the catheter into the vessel and advance along the 0.018 inch placement
guidewire until resistance is met at the proximal vessel loop.
3. 3. To prepare the repositioning sheath, remove the luer plug at the end of the sidearm
tube and flush the tube with 0.9% NaCl solution.
Place the luer plug back in the sidearm tube and secure the plug.
6. 6.
Hold tension on the proximal vessel loop to prevent bleeding. Straighten the blue
pigtail and thread it over the 0.018 inch placement guidewire (see Figure 5.31). Wet the
cannula with sterile water and backload the catheter onto the placement guidewire.
One or two people can load the catheter on the guidewire.
5. 5.
Remove the diagnostic guidewire and exchange it for the supplied 0.018 inch
placement guidewire.
4. 4.
Make the incision as close as possible to the distal loop. Insert a diagnostic catheter
(Abiomed recommends a 6 Fr AL1 or Multipurpose without side holes or 4–5 Fr pigtail
with or without side holes) over a diagnostic 0.035 inch or 0.038 inch guidewire into
the left ventricle.
Impella
®
5.0 Use in Open
Heart Surgery
If the Impella ® 5.0 Catheter
is used in the OR as part
of open heart surgery,
manipulation may be
performed only through the
9 Fr steering catheter. Direct
manipulation of the catheter
through the aorta or ventricle
may result in serious damage
to the Impella
®
5.0 Catheter
and serious injury to the
patient.
Using a Pigtail
Diagnostic Catheter with
Side Holes
When using a pigtail
diagnostic catheter with
side holes, ensure that the
guidewire exits the end of
the catheter and not the side
hole. To do so, magnify the
area one to two times as the
guidewire begins to exit the
pigtail.
a. a. Advance the placement guidewire into the Impella
®
5.0 Catheter and stabilize
the cannula between the fingers. This prevents pinching of the inlet area. The
placement guidewire must exit the outlet area on the inner radius of the cannula
as shown in Figure 5.31, and align with the straight black line on the catheter. The
catheter can be hyperextended as necessary to ensure the placement guidewire
exits on the inner radius of the cannula.
b. b.
The scrub assistant can help stabilize the catheter by holding the catheter proximal
to the motor. This will allow the implanting physician to visualize the inner radius.
The placement guidewire must exit the outlet area on the inner radius of the
catheter and align with the straight black line on the catheter. The physician can
focus on advancing the placement guidewire and, if the cannula needs to be
hyperextended, the scrub assistant is available to assist.
8. 8.
Administer heparin and achieve ACT of at least 250 seconds.
7. 7. Make a transverse incision at the guidewire for the 21 Fr catheter. Use U-stitches
(see Figure 5.30) instead of purse string sutures to avoid stenosis of the vessel after
explantation.
GP IIb-IIIa Inhibitors
If the patient is receiving a
GP IIb-IIIa inhibitor, the
Impella
® 5.0 Catheter can be
inserted when ACT is 200 or
above.
9. 9. Insert the catheter into the vessel and advance along the 0.018 inch placement
guidewire until resistance is met at the proximal vessel loop.