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SITE PREPARATION
1.
The patient should be placed in a modified Trendelenburg position, with the upper chest exposed and the head turned slightly to the opposite side of the
insertion site.
2.
For internal jugular placement, have patient lift his/her head from the bed to define the sternomastoid muscle. The venous entry site will be performed at the
apex of a triangle formed between the two heads of the sternomastoid muscle. The apex should be approximately three finger breadths above the clavicle.
3.
Prepare and maintain a sterile field throughout the procedure using standard institutional protocol for implantable devices.
PRECAUTION: Follow Universal Precautions when inserting and maintaining this device. Due to the risk of exposure to bloodborne pathogens, health care
professionals should always use standard blood and body fluid precautions in the care of all patients. Sterile technique should always be followed.
4.
Prepare the sterile field and access site using an approved prep solution and standard Surgical technique.
PRECAUTION: Use standard hospital protocols when applicable.
5.
(If applicable) Administer local anesthesia to the insertion site and the path for the subcutaneous tunnel.
VENOUS ACCESS AND GUIDE WIRE INSERTION
1.
K-DOQI Guidelines recommend the use of ultrasound guidance.
NOTE: Mini access ("micropuncture") is recommended. Follow manufacturer's guidelines for proper insertion technique.
Insert the introducer needle with an attached syringe and advance it into the target vein, in the direction of blood flow. Aspirate gently as the insertion is made.
Aspirate a small amount of blood to ensure the needle is correctly positioned in the vein.
PRECAUTION: If arterial blood is aspirated, remove the needle and apply immediate pressure to the site for at least 15 minutes. Ensure that the bleeding has
stopped and that no hematoma has developed before attempting to cannulate the vein again.
2.
When the vein has been entered, remove the syringe leaving the needle in place and place thumb over the hub of the needle to minimize blood loss and / or air
embolism.
3.
Insert the distal end of the marker guide wire into the needle hub (or mini access introducer hub) and pass it into the vasculature.
PRECAUTION: If using the "J" tipped wire provided, draw the tip of the wire back into the straightener so that only the tip of the wire is exposed.
4.
Advance the guide wire with forward motion until the tip resides at the junction of the superior vena cava and right atrium.
WARNING: Cardiac arrhythmias may result if the guide wire is allowed to pass into the right atrium.
CAUTION: Do not advance the guide wire or catheter if unusual resistance is encountered.
CAUTION: Do not insert or withdraw the guide wire forcibly from any component. The wire may break or unravel. If the guide wire becomes damaged and must
be removed while the needle (or sheath introducer) is inserted, the guide wire and needle should be removed together.
PRECAUTION: The length of the guide wire inserted is determined by the size of the patient and the anatomical site used.
PRECAUTION: Depth markings on the wire will help determine indwelling depth. Always confirm proper guide wire position using fluoroscopy.
5.
Remove the needle (or mini access introducer), leaving the guide wire in place. The guide wire should be held securely during the procedure. The introducer
needle must be removed first.
CATHETER PREPARATION AND SUBCUTANEOUS TRACT DILATION
1.
Remove the stiffening stylet from the venous lumen.
PRECAUTION: The ProGuide catheter is packaged with a guide wire stiffening stylet to facilitate placement using the over-the-wire technique and is not used with
a peelaway introducer insertion technique (see insertion technique 2 for use of stiffener component).
2.
Irrigate each lumen of the catheter with heparinized saline and clamp each extension prior to catheter insertion.
WARNING: The heparin solution must be aspirated out of both lumens immediately prior to using the catheter to prevent systemic heparinization of the patient.
WARNING: To minimize the risk of air embolism, keep the catheter clamped at all times when not in use or when attached to a syringe, IV tubing, or bloodlines.
WARNING: Patients requiring ventilator support are at increased risk of pneumothorax during subclavian vein cannulation.
CAUTION: Do not clamp the dual lumen portion of the catheter body. Clamp only the clear extension tubing.
PRECAUTION: Only clamp the catheter with the in-line tubing clamps provided.
3.
Determine the catheter exit site on the chest wall, approximately 8-10 cm below the clavicle that is below and parallel to the venous puncture site.
PRECAUTION: A tunnel with a wide, gentle arc lessens the risk of catheter kinking. The distance of the tunnel should be short enough to keep the
bifurcated junction from entering the exit site, yet long enough to keep the cuff 2-3 cm (minimum) from the skin opening site.
4.
Make a small incision at the desired exit site of the tunneled catheter on the chest wall. The incision should be wide enough to accommodate the cuff,
approximately 1 cm.
5.
Use blunt dissection to create the subcutaneous tunnel opening at the catheter exit site for the white tissue ingrowth cuff, midway between the skin exit site and
the venous entry site, approximately 2-3 cm (minimum) from the catheter exit site.
WARNING: Do not over-expand the subcutaneous tissue during tunneling. Over-expansion may delay or prevent cuff in-growth.
6.
Make a second incision above and parallel to the first, at the venous insertion site. Enlarge the cutaneous site with a scalpel and create a small pocket with blunt
dissection to accommodate the small remaining catheter loop ("knuckle") of the catheter after the peel-away sheath is removed.
7.
Attach the tunneler to the catheter's venous lumen. Slide the tip of the catheter over the tri-ball connection until it rests adjacent to the sheath stop.
8.
Slide the tunneler sheath over the catheter making certain that the sleeve covers the arterial lumen. This will reduce the drag in the subcutaneous tunnel as the
apparitional bump and arterial port pass through the tissue.
9.
With the blunt tunneler, gently lead the catheter and tunneler connection into the exit site and create a subcutaneous tunnel from the catheter exit site to
emerge at the venous entry site.
CAUTION: The tunnel should be made with care to avoid damage to surrounding vessels. Avoid tunneling through muscle.
CAUTION: Do not pull or tug the catheter tubing. If resistance is encountered, further blunt dissection may facilitate insertion. The catheter should not be forced
through the tunnel.
10. After tunneling the catheter, the tunneler can be removed by sliding the tunneler sheath away from the catheter and pulling the tunneler from the distal tip of
the catheter.
CAUTION: Avoid damage to the catheter by using a slight twisting motion.
CAUTION: To avoid damage to the catheter tip, keep the tunneler straight and do not pull it out at an angle.
CAUTION: Inspect catheter tip for damage before proceeding with procedure
INTRODUCTION OF THE VALVED PEELAWAY INTRODUCER
CAUTION: The sheath is not intended to create a complete two-way seal nor is it intended for arterial use.
CAUTION: The sheath is designed to reduce blood loss but it is not a hemostasis valve. The valve may substantially
reduce the rate of blood flow but some blood loss through the valve may occur.
1.
Insert vessel dilator into sheath until the dilator cap folds over valve housing and secures the dilator onto sheath assembly.
NOTE - Optional dilation:
•
To ease insertion of the peelaway introducer, some physicians prefer to dilate the vein before inserting
the introducer.
•
Thread the dilator(s) over the end of the guide wire and advance into the vein using a rotating motion to
assist passage through the tissue.
CAUTION: As the dilator(s) pass through the tissue and into the vasculature, ensure that the guide wire
does not advance further into the vein.
2.
While maintaining guide wire position in the vein, advance the locked peelaway introducer and dilator
assembly over the exposed guide wire and into the vein.
WARNING: Never leave the sheath in place as an indwelling catheter. Damage to the vein will occur.
3.
Hold the sheath in place and separate the dilator cap from the sheath valve housing by rocking the dilator cap off the hub.
Gently withdraw the dilator and wire from the sheath leaving the valved introducer in place.
NOTE: Leaving the guide wire in place after removing the dilator may cause the valve to leak.
CAUTION: Care should be taken not to advance the split sheath too far into the vessel as a potential kink
would create an impasse to the catheter.
DIALYSIS CATHETER PLACEMENT
1.
Advance the distal section of the catheter through the valved sheath introducer and into the vein.
PRECAUTION: To help minimize catheter kinking, it may be necessary to advance in small steps by grasping
the catheter close to the sheath.
2.
Advance the catheter tip to the junction of the superior vena cava and right atrium.
3.
With the catheter advanced and positioned, sharply snap the tabs of the valve housing in a plane perpendicular to the
long axis of the sheath to split the valve and peel partially away from the catheter.
CAUTION: Do not pull apart the portion of the sheath that remains in the vessel. To avoid vessel damage,
pull back the sheath as far as possible and peel the sheath only a few centimeters at a time.
4.
Remove the sheath completely from the patient and catheter.
5.
Press the remaining catheter loop ("knuckle") gently into the subcutaneous pocket created at the venous entry site.
WARNING: Catheters should be implanted carefully to avoid any sharp or acute angles which could compromise
the flow of blood or occlude the opening of the catheter lumens.
PRECAUTION: For optimal product performance do not insert any portion of the cuff into the vein.
6.
Attach syringes to both extensions and open the clamps. Confirm correct placement and catheter function
by aspirating blood from both lumens. Flush each lumen with heparinized saline (priming volume is
printed on the extension tubing clamp). Blood should aspirate easily.
PRECAUTION: If either lumen exhibits excessive resistance to blood aspiration, the catheter may need to
be rotated or repositioned to obtain adequate blood flow.
PRECAUTION: It is recommended that the "venous" luer connection be oriented cephalad (toward the head).
7.
Clamp the extensions immediately after flushing.
8.
Remove the syringes and replace with injection caps.
PRECAUTION: Avoid air embolism by keeping extension tubing clamped at all times when not in use and
by aspirating then irrigating the catheter prior to each use. Always aspirate first then irrigate the catheter
prior to each use. With each change in tubing connections, purge air from the catheter and all connecting tubing and caps.
9.
Correctly position the cuff and tunneled portion of the catheter.
INSERTION TECHNIQUE (1) - COMMON STEPS
PERCUTANEOUS ENTRY INTO RIGHT INTERNAL JUGULAR VEIN
WITH A VALVED PEELAWAY SHEATH INTRODUCER
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