There are a lot of closure devices. I picked this one next because we use this and I wanted to understand how to do it, and what is actually going on when I’m doing something.
The first picture is of the device. Not the most glamorous shot, but I was trying to get it in the non-folded form since it’s a little deceiving just looking at it in the tray.
Remove device from tray and fill locking syringe with 2-3cc of sterile saline. Attach syringe to stop cock and aspirate any pre-existing air.
Deflated balloon should look like below.
Inflate balloon until black marker on inflation indicator is seen. Deflate balloon and leave syringe alone.
The above is to check the balloon to ensure that it is not ruptured prior to use in the patient. The mynx is then introduced through the introducer sheath. The picture below shows an introducer sheath in the vessel.
The mynx grip is then introduced through the introducer sheath as stated above.
The balloon is inflated by advancing syringe until black marks on inflation indicator visualized.
Once the balloon is inflated, the stop cock is turned to lock the balloon in the inflated position. Locked position of stopcock is shown below.
Pull the entire mynx system back via black handle grip until resistance is felt. The first resistance or stop encountered is the balloon coming into contact with introducer sheath.
The mynx system is again further pulled back via black handle grip until resistance or second stop is noticed. This will cause the introducer sheath to be partially removed from since the balloon is pulling the introducer sheath out until the balloon hits the inner lumen of the vessel.
While holding tension open stopcock on introducer sheath. If the mynx balloon is in contact with the wall and occluding the vessel internally then there should be no blood flow through the introducer sheath stopcock. If the balloon is not under enough tension then the arteriotomy site will not be occluded and blood will flow through the introducer sheath stopcock.
While holding tension leaving introducer sheath stopcock open, advance the shuttle (gray handle in this picture, sometimes shuttle color is different).
The shuttle is advanced until a tactile click is felt indicating the sip of the shuttle has reached the balloon. The shuttle is advancing a polyethylene glycol sealant and advancer tube that is within the cannula of the shuttle. Next the introducer sheath and shuttle are pulled back toward the black handle grip until the shuttle grip once again locks to black handle grip. This leaves the advancer tube and sealant behind abutting the arteriotomy.
The distal end when the shuttle and introducer sheath with withdrawn is shown below. The balloon is intravascular and the polyethylene glycol sealant is extravascular.
While still holding tension on the black grip handle the advancer tube is pushed toward the vessel. This compresses the polyethylene glycol sealant against the arteriotomy from outside the artery. When the advancer tube is sufficiently pushed toward the artery a green indicator line on the tube can be seen.
Distally when the green mark is visualized the sealant is being compressed against the arteriotomy site and is shown below.
Hold advancer tube against sealant and arteriotomy for up to 30 seconds. Not sure where they came up with the time, but that’s the instructions per the mynx website (https://www.cardinalhealth.com/content/dam/corp/web/documents/brochure/CardinalHealth-MynxGripVascularClosureDeviceProcedureGuide.pdf). Then lay the entire device down (not holding black handle grip for traction) for up to 90 seconds. Presumably this gives the sealant time to attach externally to arteriotomy.
The syringe is pulled back all the way until locked in fully opened position (stopcock still in a closed position, therefore a vacuum is being created in syringe). The balloon is also still inflated since the stopcock is still locked at this point.
The advancer tube is aligned with tract along the tissue and light pressure held over the artery (in preparation to provide counter pressure on the artery when the balloon is removed). Once the advancer tube is stabilized in position the stopcock on the balloon syringe is opened allowing the balloon to deflate.
The mynx system is then removed via the black grip handle (whereby the deflated balloon passes through the arteriotomy and the sealant and the advancer tube until completely out of the patient).
The advancer tube is then removed from the patient. There will be a small puncture through which blood can follow the path of the balloon that was withdrawn. When the blood comes in contact with the sealant, the sealant expands thereby closing off the tract which the balloon was removed through.
The sealant is supposed to be resorbed by the body within 30 days. Manual compression can then be held as needed or desired. This is then followed by a sterile dressing.
A study by Gongidi VR et al demonstrated safe ambulation at 1.03 +/- 0.16 hours for diagnostic cardiac angiogram (original mynx study with lay flat time post procedure of 2.5 +/- 2.1 hours).[1] How long will your patient lay flat? It’ll be up to the attending and if an intervention requiring anticoagulant or antiplatelets are used.
Side notes, green shuttle handle is found on 6F and 7F closure devices while the gray shuttle handle is found on 5F device.
Hopefully the pictures above help clarify what is going on internally for parts of the steps that we can’t visualize. Everyone learns differently and videos are fun too. Here are some youtube links that were helpful.
Cartoon version of what’s going on
Live demonstration of deployment
1. https://evtoday.com/articles/2013-oct/mynx-vascular-closure-device-early-ambulation
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