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alternative for preventing amputation or death.
8.
When the prosthesis is used for arteriovenous access some redness and swelling may be present over the implant area for a
few days following implant.
9.
Insu cient data is available on which to base any conclusions regarding the use of the Omni ow II vascular prosthesis for
aortocoronary bypass procedures.
10.
Failure to heparinize the prosthesis (i.e. in the case of patients who cannot tolerate heparin) may result in a higher likelihood
of thrombosis or occlusion post-implantation, the extent of which has not been established.
11.
Omni ow II cannot grow in diameter or length and thus should not be implanted into infants or children unless a plan for its
replacement is established and that no other suitable alternative treatment option exists.
Thrombectomy
Prompt intervention when occlusion occurs has been found to restore prosthetic function. Therefore the patient should be advised
to report to the clinician if symptoms return. When performing a thrombectomy choose an embolectomy catheter of the appropriate
size and follow the catheter manufacturer's instructions for use.
To avoid damage to the wall and ow surface of the prosthesis:
1.
Do NOT exert undue pressure when in ating the balloon
2.
Do NOT exert undue force when withdrawing the catheter from the prosthesis.
Contraindications
The prosthesis should not be used in patients with a known hypersensitivity to ovine material or glutaraldehyde.
Potential Complications with the use of Vascular Prostheses
Complications may occur with the use or in conjunction with any vascular prosthesis and include but are not limited to: infection,
thrombosis/ occlusion, dilatation, leakage, aneurysm formation, pseudoaneurysm formation, suture pullout and adverse tissue
responses. Ongoing patient monitoring is recommended.
Pre-implant preparation
Prepare a sterile basin with adequate sterile physiological saline to cover the prosthesis, a sterile 20 ml syringe, sterile heparin 5,000
I.U. per ml.
Removing the prostheses from the container
STRAIGHT VASCULAR PROSTHESIS
1.
Remove the seal and cap from the glass tube. Remove the silicone stopper with sterile forceps. The forceps and
stopper are discarded. Fig. 1.
2.
Aseptically remove the prosthesis from the glass tube by grasping the end of the glass mandrel with sterile forceps
and lifting it gently out of the glass tube. Fig. 2. The hook on the bottom of the mandrel will prevent the graft from
slipping o the mandrel.
3.
Grasp the mandrel by the hook, turn it upside down and allow the prosthesis to slide into the basin of sterile saline.
If the prosthesis does not slide o easily, gently push it down the mandrel. Do NOT pull the prosthesis.
CURVED VASCULAR PROSTHESIS
1.
Aseptically remove the sterile inner bag containing the prosthesis from the outer bag. Fig. 3. Only the inner bag is
sterile.
2.
Cut the corner of the inner bag with sterile scissors and allow the storage solution to drain into a container. Fig. 4.
Discard the container of storage solution.
3.
Remove the prosthesis from the inner bag and place it into the basin of sterile physiological saline.
Rinsing the prosthesis
STRAIGHT VASCULAR PROSTHESIS
4
1.
Use a sterile syringe to ush the lumen of the prosthesis with 20 ml of sterile physiological saline. Fig. 5. Repeat at
least twice.
2.
Clamp one end of the prosthesis. Insert sterile heparin at a concentration of 5,000 I.U. per mL into the lumen of the
prosthesis so that the entire inside surface of the graft is coated with the solution (50,000 I.U in 10 mL is su cient
for prostheses 35 cm and longer and 25,000 I.U. in 5 mL is su cient for those shorter).
3.
Apply a clamp to the other end of the prosthesis.
4.
Place the prosthesis back into the basin completely covered by the sterile saline until it is time for implantation. This
should be a minimum of 10 minutes.
When it is time to implant the prosthesis, remove the clamps from the prosthesis and allow the heparin and saline to drain
out.
CURVED VASCULAR PROSTHESIS
The curved prosthesis is rinsed in the same manner as described above for the straight prosthesis. The curved con guration
is maintained throughout the procedure. Fig. 6. Do NOT straighten the prosthesis.
Implantation
Prepare the incisions in the normal fashion.
Use of a hollow tunnelling instrument.
STRAIGHT VASCULAR PROSTHESIS
Form a tunnel for the prosthesis using a metal or plastic hollow tunnelling instrument and pass the prosthesis through the
instrument. Fig. 7.
CURVED VASCULAR PROSTHESIS
Marking the proposed graft layout on the skin with a sterile surgical marker may facilitate nal positioning of the prosthesis.
Maintain the curve of the graft by inserting 2 hollow tunnelling instruments and passing both straight sections of the graft
through simultaneously from the distal to the proximal incision. Fig. 8. Ensure that the graft does not kink at the curve
during placement.
Carefully remove the tunnelling instrument when the graft has been correctly placed.
Anastomoses
1.
When fashioning the ends for the anastomoses it is essential to cut o those portions of the prosthesis that were clamped,
as clamping can damage the tissue matrix. No special cutting technique is required given the biosynthetic material of the
graft..
2.
Mono lament polypropylene is the preferred suture material. During suturing evert the edges of the prosthesis and ensure
the full wall thickness and a mesh eyelet are taken up with each stitch. Fig. 9.
3.
Prior to completion of the second anastomosis ush the prosthesis with blood to ensure complete removal of the heparin.
4.
An intra-operative angiogram may be performed at the time of the procedure to document function. Ensure that the artery
rather than the prosthesis is used for the injection.
At the completion of the procedure the patient record labels supplied with the prosthesis should be a xed in the patient and
hospital records.
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