Preparation & Application - Delivery Device Preparation

The BioGlue Surgical Adhesive and its reusable syringe delivery device consists of: main delivery unit, black delivery device plunger, solutions syringe, and applicator tips.

1. Remove the main delivery unit and black delivery device plunger from their packaging. While pushing upward on the small latch at the back of the main unit, insert the plunger, ribbed side downward, into the front of the main unit.
   
   

   NOTE: The white plunger supplied with the syringe will not work with the delivery device.

2. Still holding the small latch upward, retract the delivery device plunger completely back.
   
   
3. Remove a solutions syringe from its packaging. Align the large and small barrels of the solutions syringe with the corresponding delivery device plunger heads in the main delivery unit. From the side of the delivery device, slide the syringe into position, leading with the large barrel. Slide the delivery device plunger forward until resistance is felt.
   
   

   CAUTION: Do not compress the main delivery unit trigger mechanism while attaching the solutions syringe.

4. Remove an applicator tip from its packaging and inspect the collar portion of the tip to ensure that the pointer portion is directly over the larger port. If not, rotate the locking collar on the shaft until the pointer is over the larger port.
   
   
5. While firmly grasping the syringe, nose upward, turn the syringe cap 90º counterclockwise and remove the cap by rocking it from side-to-side. Align the tip with the syringe using the corresponding notches on each and place the tip on the syringe.
   
   

   CAUTION: Take care not to spill solution from the syringe during assembly.

   CAUTION: Do not compress the main delivery unit trigger mechanism while attaching the applicator tip.

6. Lock the applicator tip in place by pushing the tip firmly toward the solutions syringe and rotating the tip collar 90º clockwise.
   
   

   CAUTION: Before using BioGlue in the procedure, the applicator tip must be primed. Refer to Site Preparation - Syringe Air Space Removal and Applicator Tip Priming.

7. If using an applicator tip with a flexible extension, a desired angle may be created by bending the extension at the appropriate location to the desired angle and holding for 3-5 seconds. The angle created should be maintained for up to 5 minutes.
   
   
8. To remove occluded applicator tips, grasp the applicator tip collar, rotate the tip collar counterclockwise, and lift the tip off the solutions syringe by rocking it side-to-side.

Preparation & Application - Syringe Preparation

The BioGlue Surgical Adhesive Syringe delivery system consists of: syringe, syringe plunger, and applicator tips.

Inside the BioGlue Syringe box there are two separate pouches. One contains the syringe and the syringe plunger, and one contains four applicator tips.

The 10mL BioGlue Syringe box includes an additional pouch containing three, 12mm Spreader Tips.

1. Remove the syringe, syringe plunger, and applicator tips from their packaging. While holding the syringe upright, tap the syringe until the air bubbles in the solutions rise to the top of the syringe.
   
   

   NOTE: Continue to hold the syringe upright during the entire assembly of the delivery system to keep the bubbles toward the top of the syringe.

2. Remove an applicator tip from its packaging and inspect the collar portion of the tip to ensure that the pointer portion is directly over the larger port. If not, rotate the locking collar on the shaft until the pointer is over the larger port.
   
   
3. While firmly grasping the syringe, nose upward, turn the cartridge cap 90º counterclockwise and remove the cap by rocking it from side-to-side. Align the tip with the cartridge using the corresponding notches on each and place the tip on the syringe.
   
   

   CAUTION: Take care not to spill solution from the syringe during assembly.

4. Lock the applicator tip in place by pushing the tip firmly toward the syringe and rotating the tip collar 90º clockwise.
   
   
5. While keeping the syringe upright, align the small and large barrels of the syringe with the corresponding syringe plunger heads and slide the plunger into the back of the syringe until resistance is felt. The syringe delivery device is now assembled.
   
   

   CAUTION: Do not lay the assembled device on its side until all air has been purged (see next paragraph).

   CAUTION: Before using BioGlue in the procedure, the syringe must be purged of the residual air space and the applicator tip must be primed. Refer to Site Preparation - Syringe Air Space Removal and Applicator Tip Priming.

6. If using an applicator tip with a flexible extension, a desired angle may be created by bending the extension at the appropriate location to the desired angle and holding for 3-5 seconds. The angle created should be maintained for up to 5 minutes.
   
   
7. To remove occluded applicator tips, grasp the applicator tip collar, rotate the tip collar counterclockwise, and lift the tip off the syringe by rocking it side-to-side.

Site Preparation - Syringe Air Space Removal and Applicator Tip Priming

1. The target surgical field must be properly prepared prior to either removal of the residual air space, priming, or applying BioGlue. BioGlue works best when the target surgical field is dry. A dry surgical field can be described as a field that does not restain with blood within 4-5 seconds after wiping dry with a surgical sponge.
   
   

   CAUTION: Do not attempt to apply BioGlue to a field that is too wet. Application of BioGlue into a wet field may result in the failure of BioGlue to adhere.

2. The residual syringe air space must be removed prior to BioGlue application. Again, it is important to hold the assembled syringe upright to ensure that the air bubbles in the solutions are located at the top of the syringe. Purging of the air space can now be accomplished using two different methods:
   
   
   1. Compress the plunger only until the solutions are even with the top of the syringe body. Once the residual air space has been removed the syringe is ready for priming (refer to Step 3) and immediate use.
      
      
   2. Compress the plunger until both solutions can be visibly seen in the base of tip. The airspace has now been removed, but this tip is now occluded with polymerized BioGlue and will need to be changed prior to priming (refer to Step 3) and application to the target site.
      
      

   NOTE: Each syringe only needs to be purged of residual airspace upon its initial use.

3. Each applicator tip must be primed prior to BioGlue application. Priming ensures the BioGlue solutions are properly mixed. The surgeon should compress the plunger and expel a narrow ribbon of BioGlue approximately 3 cm long onto a sterile disposable surface (e.g., sponge, gauze, or towel).
   
   
4. The surgeon should examine the material expelled during priming and ensure that it is of uniform light yellow to amber color and that it is free from air bubbles. If this material looks colorless or contains bubbles, repeat the prime as outlined in Step 2 until the device delivers a uniform liquid with no bubbles.
   
   

   CAUTION: Avoid direct contact with material expelled during priming.

5. When the applicator tip has been properly primed, proceed immediately to application.
   
   

   CAUTION: BioGlue polymerizes very quickly. The surgeon must apply BioGlue immediately after priming. Pausing between priming and application can cause polymerization of BioGlue within the applicator tip. Should this occur, replace the obstructed tip with a new tip and repeat the steps for applicator tip priming. Do not continue to apply pressure to the plunger once the tip has occluded.

General Techniques for the Use of BioGlue in Surgery

1. BioGlue works best when the target surgical field is dry.
   
   
   • A dry surgical field can be described as a field that does not restain with blood within 4-5 seconds after wiping dry with a surgical sponge.
     
     
2. Tissues surrounding the target surgical site should be protected from the unintentional application of BioGlue.
   
   
   • The most effective method of protection is to cover any non-target tissues with moist sterile gauze pads.
     
     
   • These protective pads should be removed before complete polymerization occurs.
     
     

   Warning: Animal studies have shown that direct application of BioGlue to the exposed phrenic nerve can cause acute nerve injury. BioGlue application to the surface of the heart can cause coagulation necrosis that extends into the myocardium, which could reach underlying conduction tissue and may cause acute, focal sinoatrial node degeneration.

3. Apply an even coating of BioGlue to the target area.
   
   
   • In general, use an approximately 1 to 3 mm thick coating for vessels that are greater than 2.5 cm in diameter or an approximately ½ to 1 mm thick coating for vessels that are less than 2.5 cm in diameter.
     
     

   CAUTION: Avoid contact of the BioGlue with blood-saving devices, such as cell savers and pumps.

   CAUTION: Clamp and depressurize vessels prior to applying BioGlue to targeted anastomoses.

   CAUTION: Avoid suctioning BioGlue into the vessels when applying it to targeted anastomoses.

4. If BioGlue is inadvertently applied to non-target tissues, allow the adhesive to polymerize completely.
   
   
   • Then, using forceps and scissors, carefully dissect the polymerized BioGlue from the unintended area.
     
     

   CAUTION: Do not peel BioGlue away from an unintended site, as this could result in tissue damage.

   CAUTION: Polymerized BioGlue has space occupying properties. Caution should be used in the application of BioGlue to avoid compression of adjacent structures.

5. Do not compress the area of application or subject it to any extra pressure.
   
   
   • BioGlue does not require any clamping or compression in order to polymerize.
     
     
   • BioGlue works optimally when it is allowed to polymerize without any manipulation for a full two minutes.
     
     
6. When BioGlue has completely polymerized, the surgeon may trim away any excess material or irregular edges with scissors and forceps.

Specific Techniques for the Use of BioGlue in Aortic Dissection Surgery

1. The dissected layers of the aorta should be initially cleared of blood and thrombus material and should be dried, to the extent possible, with surgical sponges.
   
   
2. For the distal end of the dissection repair, insert a balloon catheter into the true lumen to define the distal terminus for the application of BioGlue.
   
   
   • In addition, the dissected layers of the aorta should be closely approximated by inserting a dilator, sponge, or catheter into the true lumen to preserve the natural architecture of the vessel.
   
   
3. BioGlue should then be dispensed into the false lumen as far distally as the distal balloon catheter will allow.
   
   
   • Filling the false lumen should proceed from distal to proximal with a spiraling out motion for smooth application.
     
     
   • Completely fill the false lumen with BioGlue; avoid overfilling the false lumen and spilling BioGlue into the true lumen or surrounding tissue.
     
     
4. For the proximal end of the dissection repair, the dissected layers of the aorta should also be closely approximated by using a dilator, sponge, or catheter.
   
   
   • If necessary, moist gauze pads should be placed over the aortic valve leaflets to protect them from inadvertent application of BioGlue.
     
     
   • BioGlue should then be dispensed to fill the false lumen.
     
     
   • Graft material may be sutured directly onto the tissues adhered and reinforced with BioGlue at both the proximal and distal aspects of the dissection repair.
     
     
   • Allow BioGlue to completely polymerize without any manipulations for a full two minutes prior to suturing through the adhered tissue layers.