Flex-Neck® ExxTended™ Catheter Implantation Procedure Kit Upper Abdomen Catheter Placement Upper Chest Catheter Placement Instructions for Use
Flex-Neck ExxTended Catheter Kit I NSTRUCT I ONS FOR USE Table of Contents Section A – Instructions for Flex-Neck ExxTended Catheter Implantation Stencils Kit Section B – Instructions for Lower Catheter Implantation for Upper Abdomen and Upper Chest Exit-Site Section C – Instructions for Upper Abdominal Catheter: Sizing, Connecting and Placement Section D – Instructions for Upper Chest Catheter: Sizing, Connecting and Placement Section E – Catheter Connector Instructions Product Description Each Flex-Neck
marked by the Flex-Neck ExxTended Catheter Implantation Stencils, in the clinic or during pre-op evaluation. At a minimum, the patient should be evaluated preoperatively to determine a proper, accessible location for the catheter exit site. These marking should be noted for reference during implantation. 3.
When satisfactory locations for the Exit-Site, Circle , and the arcuate bend are achieved, mark the secondary incision site, Rectangle . This is where the Tunneling Tool with the attached ExxTended Catheter will temporarily emerge. With proper implantation of the Upper Catheter segment, the black marker ring will rest at the level of the secondary incision. Confirm that selected exit-site is free from open collar area , infraclavicular region, median sternotomy zone, and fleshy part of breast .
Regardless of which implantation technique is used, ALWAYS make sure to: a) Place the deep cuff within the rectus muscle. b) Angle the catheter inferiorly as it passes through the rectus muscle to direct it into the pelvis. c) Do not twist or rotate the catheter; verify that the radiopaque stripe is straight throughout the procedure. d) Test Lower Catheter patency by infusing a minimum of 60 cc of sterile saline and observing the outflow rate before proceeding with the implantation procedure.
2. Record that distance, “A”, in centimeters, between the primary and secondary incision sites. This distance, A, represents the total length needed when combining Upper and Lower Catheters. See Figure 8. 3. Select and note a potential location where the Upper and Lower Catheters will be connected together by the internal double-barbed Titanium Connector.
connecting the Upper Catheter, ensure that the catheter is oriented so that the cuff and exit site face laterally. 4. Tie a non-absorbable suture, such as 2-0 or 0-polypropylene, around each catheter, behind the barb on the Titanium Connector. The two sutures may then be tied to each other to further prevent tubing separation. 5. Test the integrity of the junctions by pulling firmly on each catheter in turn while holding the connector. Do not dislodge the deep (rectus) cuff during this pull test.
Preparation for Sizing the Upper Chest Catheter 1. Catheters should NOT be trimmed until after the Lower (abdominal) Catheter has been implanted and the rectus cuff is securely in place in the muscle, and after the secondary incision has been made at the marked Rectangle . This will prevent catheter waste in case some aspect of the surgical procedure should change, thus modifying the measurements. 3.
Alternative Measuring and Cutting Instructions for the Upper Chest Catheter 1. Position the Upper Catheter on the abdominal wall with the black marker ring on the secondary incision, Rectangle . 2. Overlap the Upper and Lower catheters and choose an appropriate location to cut and join the two. See figure 16 NOTE : Keep in mind that one of the catheters will need to be further shortened as described in step 5 below. 3. Cut the two catheters at the location selected in step 2. 4.
Finalizing Catheter Placement Merit Medical Systems, Inc. provides three options for tunneling the catheter through the skin exit-site location. The technique for creating the exit-site will vary according to the particular tool selected to perform this function. A plastic retrograde Tunnelor® Tool , plastic antegrade Faller Trocar, and stainless steel antegrade Faller Trocar are sold separately. 1. The exit-site should be approximately 3-4 cm distal to the exit site cuff if possible.
Manufacturer: Merit Medical Systems, Inc. 1600 West Merit Parkway, South Jordan, Utah 84095 U.S.A. 1-801-253-1600 U.S.A. Customer Service 1-800-356-3748 Authorized Representative: Merit Medical Ireland Ltd, Parkmore Business Park West, Galway, Ireland www.merit.
