Glubran 2 Seal

KIT GLUBRAN 2 SEAL
New extravascular device for occlusion of the femoral arterial access site.
The Kit is made up of Glubran 2 glue and its applicator “Glubran 2 Seal Device”.
At present, “Glubran 2” glue is the occlusion system recommended after procedures such as diagnostic and interventional catheterization through femoral retrograde and antegrade access.
“Glubran 2” glue is used to occlude arterial access sites in anunique and revolutionary method, absolutely innovative with regard to those used up to today. The procedure is simple, quick and extremely safe for its control in releasing under scopy.
GLUBRAN 2 SEAL DEVICE applicator
“Glubran 2 Seal Device” is the applicator specially studied to be hooked and made slipping along the outer surface of the introducer sheath , to go easily through the subcutaneous adipose tissue and to stop itself into the point where the glue is released.
The applicator is in 5-6 French and 7-8 French sizes.
Advantages
  • occlusion of the femoral access site in retrograde and antegrade position
  • release of the glue in extravascular site
  • no need to interrupt the anticoagulant therapies
  • fast and safe occlusion due to the remarkable reactivity and adhesiveness of the glue
  • reduction of any infections connected to the bacteriostatic activity of the glue
  • biocompatible
  • guarantees the occlusion of the femoral access site even when the application is in the femoral artery, deep or superficial, femoral bifurcation, by-pass (PTFE, Dacron, venous) and calcific vessels
  • opportunity to immediately repunching the artery
  • requires a short learning curve
  • earlier patient’s walking activity
  • reduction of hospital stay costs due to the early discharge of the patient
  • execution of the procedure in complete safety by carefully following the application steps

Glubran 2 Seal - Technical card
FEATURES

The Glubran 2 Seal Device consists of a steel cannula (1) with a luer-lock attachment in polyamide at its proximal end (2), which is connected to the syringe filled with Glubran 2, and a slide in polypropylene (3) at its distal end for hooking to the vascular introducer.
The applicator is radiopaque and comes in sizes of 5-6 French and 7-8 French.
INDICATIONS
To be used in haemostasis procedures with Glubran 2 glue during the removal of introducers in femoral endovascular percutaneous procedures.
USE: DESCIPTION
"Glubran 2" glue is delivered by the "Glubran 2 Seal Device" applicator along the outer surface of the procedural sheath, in the area between the fascia and the femoral artery. Since the sheath is inside the artery, the glue cannot accidentally enter the lumen of the vessel.
The radiopacity of the applicator, combined with the prior injection of contrast medium in the applicator itself, allows for the correct release of the glue in the tissue below the fascia, over the arteriotomy site.
The immediate reaction of the glue with the tissue below the fascia provides a perfect occlusion of the arteriotomy, ensuring a greater patient comfort and an early ambulation.
The applicator and the procedural sheath have to be removed together, without modifying the traditional procedure of sheath removal. The manual compression has to be maintained for 3 minutes only and without interruption.
/ Correct position of the applicator with regard to the fascia and to the arteriotomy in a procedure with retrograde access
/ Correct position of the applicator with regard to the fascia and to the arteriotomy in a procedure with antegrade access
METHOD OF USE
STEP 1 - Withdraw the introducer to create the necessary space for attaching the applicator (approx. 2 cm). (PHOTO 1) /
If the walls of the introducer have collapsed, reinsert the persuader into the introducer before attaching the applicator. (PHOTO 2) /
STEP 2 - Make a 1cm cut in the skin (scalpel 11), taking care to dissect the subcutaneous fibrous layers surrounding the introducer (PHOTOS 3 / 4) with the blade, moving from the bottom to the top. /

STEP 3 - Attach the applicator to the introducer as follows: place the index and middle fingers of your hand under the introducer as a support base. Press down on the applicator so that it attaches to the introducer from the front end.
(PHOTOS 5 / 6) /

STEP 4 - Move the applicator forward: hold the introducer in place with one hand while the first finger of the other hand presses down on the applicator connector (PHOTO 7). /
A significant increase in resistance is noticed as soon as the tip of the applicator meets the fascial plane: at this point, stop pressing (PHOTO 8). /
STEP 5 - Find the position of the applicator (radiopaque):
a) in relation to the artery, with an arteriography (PHOTOS 9 /10)
b) in relation to the fascia by injecting 0.1 ml of contrast medium in the applicator. /

If the contrast medium spreads below the muscle fascia, the applicator was positioned correctly.
(PHOTOS 11 / 12)
WARNING: If the contrast medium spreads above the muscle fascia, push the applicator further in and repeat the injection of the contrast medium until the correct position is obtained. /

STEP 6 - Draw up 0.20 ml of glue in a 1 ml syringe with luer attachment.
(PHOTOS 13 / 14) /

STEP 7 - Screw the syringe to the applicator (PHOTO 15) /
STEP 8 - Inject the glue slowly and continuously. (PHOTO 16)
WARNING: If injected too quickly, the glue could flow back. /
Distribution of the glue between the fascia and the artery in a procedure with retrograde access (PHOTO 17) and anterograde access. (PHOTO 18) /

STEP 9 - At the end of the injection, the applicator and introducer must be immediately removed together by grasping them with one hand. (PHOTO 19) /
At the same time, perform the manual compression according to the traditional method, holding it for 3 minutes without interruption. (PHOTO 20) /
ADVANTAGES
  • the haemostatic and adhesive properties of Glubran 2 allow for the occlusion of the femoral access site in both the retrograde and antegrade positions
  • release of the glue in extravascular site
  • no need to interrupt anticoagulant therapies
  • does not require the use of guides and there is no need to replace the procedural sheath
  • fast and safe occlusion due to the remarkable reactivity and adhesiveness of the glue with the tissues, blood and body fluids
  • reduction of any infections connected to the procedure due to the bacteriostatic activity of the glue
  • biocompatible
  • the radiopacity of the applicator coupled with the possibility to inject contrast medium, makes the application completely radiological, allowing for the treatment of particularly complex cases such as atypical femoral access, very thin or obese patients
  • guarantees the occlusion of the arteriotomy even when applied to deep or superficial femoral arteries, femoral bifurcation, by-pass (PTFE, Dacron, venous) and calcific vessels
  • opportunity to immediately re-puncture the artery
  • requires a short learning curve
  • earlier ambulation, improved patient comfort
  • reduction of hospital stay costs
  • totally safe procedure when following the application guidelines
CONTRAINDICATIONS
There are no contraindications in the use of the device.
WARNINGS
  • The safety and efficacy of the device has not yet been established in patients with blood pressure above 180/110mmHg. In case of systolic blood pressure values greater than or equal to 180, administer anti-hypertensive medication and reduce the pressure before applying the device. In these cases, apply a compressive bandage.
  • The safety of the device has not yet been established in patients with underlying systemic or cutaneous infections.
  • The safety of the device has not yet been established in pregnant and lactating patients.
  • The safety of the device has not yet been established in patients with heavy bleeding from the access site of the introducer. (to informal Preliminary studies have obtained good results when the glue is injected together with 0.1 ml of Lipiodol (contrast medium), which prevents it from consolidating inside the device.
  • The device must not be used in patients with significant scarring in the puncture site.
  • The radiopacity of the product also allows positioning of the slide under fluoroscopic control. In this way, particularly in case of obese patients or atypical femoral accesses, the slide can be positioned in complete safety by monitoring the distance from the arterial plane.
  • Do not use the device in patients undergoing percutaneous procedures with introducers smaller than 5 French or larger than 8 French.
  • The proper functioning of the product is only guaranteed with percutaneous introducers whose outside diameters fall within the declared French tolerances.
  • The device must not be used with introducers that have a rough surface.
  • Do not use if the packaging or device is open or damaged.
  • The device cannot be reused or re-sterilised.
  • The Glubran 2 Seal must not be used in patients who are sensitive to Glubran 2 glue.
  • The descent of the device along the introducer must be interrupted when it meets resistance caused by contact with the fascia. 0.1 ml of contrast medium must always be injected; if the contrast medium is distributed between the fascia and the artery, then the glue can be injected. If the contrast medium spreads above the fascia, the device must be pushed in further and a new bolus of 0.1 ml of contrast medium must be injected to check the correct positioning.
  • The medical device must only be used by trained personnel.
INTERACTIONS
  • Do not apply the active ingredient, Ipamidol, radiological iodinated contrast medium (Iopamiro, injectable solution) because it may inactivate the properties of the Glubran 2 glue.
  • The mixing of Glubran 2 with the Lipiodol contrast medium delays the start of the polymerisation process.
STORAGE
Temperature between 0°C and +4°C
PRODUCT CODE
KIT G2-SL 5/6
KIT G2-SL 7/8
CLASS
Medical Device - class IIa, certified CE 0476