Perclose ProGlide. Deployment Steps. Suture-Mediated Closure System Abbott. All rights reserved. ANZ /11

Transcription

1 Deployment Steps

2 SUTURE TRIMMER Handle Needle Plunger Collar Lever Marker Lumen Body Foot QuickCut Link Foot (Deployed) Proximal Guide Guide Wire Exit Port Distal Guide Marker Port Sheath posterior side of device 1

3 POSITIONING Needle Plunger Marker Lumen Lever Marker Port Distal Guide (Location of Foot) Insert the over a standard 0.038" or smaller guide wire. Remove the guide wire when the guide wire exit port (of the ) is at skin level. Advance the straight into the artery coaxial to the tissue tract until arterial flow is seen through the marker lumen, indicating the foot is intraluminal. Discontinue advancement as soon as arterial flow is seen through the marker lumen. 2

4 FOOT DEPLOYMENT Needle Plunger Marker Lumen Lever QuickCut Link Foot Foot While keeping the device at a 45º angle, lift the lever up to deploy the foot inside the artery. With the lever up, gently retract the device at a 45º angle until marking has stopped indicating the foot is in position against the anterior arterial wall. 3

5 NEEDLE DEPLOYMENT Needles Needles Needle Plunger a Foot Link b Foot Link Needle Tip Marker Lumen Collar Cuff Foot While maintaining a 45º angle, and stabilizing the device with your left hand by holding the proximal guide, fully depress the plunger until the collar is touching the body of the device. This will deploy the needles and create the suture loop. 4

6 SUTURE RETRIEVAL Lateral View of CFA Wall Extraluminal View of CFA Wall b Intraluminal View of CFA Wall QuickCut a Needle Plunger Foot While continuing to stabilize the device with your left hand, retrieve the suture by removing the plunger from the device. Retract the plunger until the suture is pulled taut. Only one blue rail suture is presented. Utilizing either the QuickCut mechanism (a) or sterile scissors (b), cut the plunger free by cutting the BLUE suture approximately 1 cm below the WHITE link. 5

7 FOOT PARKING Suture Marker Lumen QuickCut Lever Suture Needle Plunger Relax the device and return the lever to its original position to park the foot. 6

8 SUTURE PRESENTATION Guide Wire Exit Port Deliberately withdraw the until the guide wire exit port is at skin level. Remove the two suture ends from the device. There should be one BLUE suture (the rail suture BLUE TAIL IS THE RAIL) and one WHITE suture (the non-rail WHITE MAKES IT TIGHT). 7

9 KNOT MANAGEMENT Double-Load Technique Keeping the suture coaxial to the tissue tract, withdraw the device with the right hand while maintaining tension on the rail suture with the left index finger. After the tip of the ProGlide sheath is removed, apply back tension to the rail limb (by rolling the left wrist) to advance the knot toward the arteriotomy. 8

10 KNOT MANAGEMENT Double-Load Technique (continued) Maintain tension on the rail limb andpick up the non-rail limb with the right hand. Place the non-rail limb on the left index finger on top of the rail limb and hold both sutures in place with the left thumb. Pick up the Suture Trimmer with your right hand. Using bow string technique, load the Suture Trimmer on to both suture limbs. Keep the Suture Gate open while maintaining tension on both Suture Limbs until the Suture Trimmer is oriented co-axial to the limbs. Keeping the Suture Trimmer loaded onto and co-axial to the Suture Limbs, advance the Suture Trimmer down into the tissue tract to the level of the artery. 9

11 KNOT MANAGEMENT Double-Load Technique (continued) Release the non-rail limb from under the left thumb and move into the single-handed position. The rail limb should remain securely wrapped around the left forefinger. Complete the knot advancement by placing the Suture Trimmer under the left thumb. Maintain constant, gentle, co-axial tension by keeping the rail limb of suture in-line with the Thumb Knob. Remain in the single-handed position for 10 seconds. Move the Suture Trimmer slightly cranial and then back to a 45 degree angle. Tighten the knot by gently pulling on the WHITE non-rail limb (WHITE MAKES IT TIGHT) and hold for 10 seconds. 10

12 HEMOSTASIS Remove the Suture Trimmer or Snared Knot Pusher from the tissue tract and test for hemostasis by having the patient cough or bend his/her leg. If hemostasis is achieved, continue to next step. If additional hemostasis is desired, load the BLUE rail suture and assume single-handed position for 20 seconds. Tighten the knot again by pulling on the WHITE non-rail limb. 11

13 SUTURE TRIMMING While holding constant back tension on the Suture Limbs, load both limbs into the Suture Trimmer and advance to the arteriotomy. Trim the sutures by pulling back on the red Trimming Lever. Keep the Trimming Lever pulled back during retrieval of the Suture Trimmer and remove the trimmed suture from the tissue tract. 12

14 KNOT DELIVERY Artery During Step 2, the needles are being advanced to engage with the foot within the artery. Link The needles connect with the link to create a loop. The suture is released from the posterior needle. During Step 3, the rail end of the suture is being pulled by the anterior needle. 13

15 Please contact your local sales representative for more info. Abbott Vascular Australia Level 8, 15 Talavera Road North Ryde NSW 2113 Tel: Tel: Fax: Abbot Vascular New Zealand Level 3, 6 Kingdon Street New Market Auckland Tel: Tel: Fax: Information provided for Health Care Professionals use only. Not to be distributed or shown to the public. Product is subject to prior training requirement as per the Instruction for Use. Caution: This product is intended for use by or under the direction of aphysician. Prior to use, it is important to read the package insert thoroughly for Instructions for Use, Warnings and Potential Complications associated with use of this device. Information contained herein is for distribution for Australia and New Zealand ONLY. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. All drawings are artist's representations only and should not be considered as an engineering drawing or photograph. Photo(s) on file at Abbott Vascular. is aregistered trademark of the Abbott Group of Companies. 14