Transoral
injection guidelines^1,2

The following are required for the transoral vocal fold injection procedure:

• PROLARYN GEL or PROLARYN PLUS syringe(s)
• Appropriate size needle(s)
• Nasopharyngoscope

1. Prepare patient for nasopharyngoscopy and anesthetize using standard methods. Local anesthesia is not required but may be utilized at the injection site.

   
   LOCATION AND DIRECTION OF NEEDLE PLACEMENT FOR TRANSORAL INJECTION

2. Prepare the syringe(s) of PROLARYN GEL or PROLARYN PLUS, injection needle(s), and nasopharyngoscopic equipment before the surgical injection. A new injection needle may be used for each syringe, or the same injection needle may be connected to each new syringe.
3. Remove foil pouch from the carton. The pouch can be opened and the syringe dropped onto the sterile field when required. A small amount of moisture is normally present inside the foil pouch for sterilization purposes; this is not an indication of a defective product.
4. Remove the Luer syringe cap from the distal end of the syringe prior to attaching the needle. The syringe can then be twisted onto the Luer lock fitting of the needle. The needle must be tightened securely to the syringe and primed with PROLARYN GEL or PROLARYN PLUS. Slowly push the syringe plunger until PROLARYN GEL or PROLARYN PLUS extrudes from the end of the injection needle. If leakage is noted at the Luer fitting, it may be necessary to remove the needle and clean the surfaces of the Luer fitting or, in extreme cases, replace both the syringe and the injection needle.

   
   NEEDLE NOT CORRECTLY ATTACHED; ROTATE TO VISUALIZE GREEN DOT

   
   

   
   NEEDLE CORRECTLY ATTACHED

   
   

   
   TRANSORAL NEEDLE
   25 cm long overall
   16-gauge malleable shaft

   
   

   
   TRANSORAL NEEDLE TIP
   24-gauge, 1-cm tip
   Marker at 5 mm

5. Place the nasopharyngoscope to precisely visualize the needle position and PROLARYN GEL or PROLARYN PLUS volume during augmentation.
6. Position injection needle for transoral vocal fold injection. PROLARYN GEL or PROLARYN PLUS should be injected lateral to the thyroarytenoid muscle. NOTE: Do not inject into a blood vessel.
7. With needle location visually confirmed through the nasopharyngoscope, slowly push the plunger of the syringe to start the injection. After the initial injection, the patient should be asked to phonate and cough to disperse PROLARYN GEL or PROLARYN PLUS throughout the vocal fold. Additional PROLARYN GEL or PROLARYN PLUS is injected until the vocal folds touch during phonation at a position midway between the anterior commissure and the vocal processes.
8. Some tissue planes may be difficult to inject. If significant resistance is encountered when pushing the plunger, the injection needle should be pulled back about 1 to 3 millimeters (with the needle still in the vocal fold tissue) and the plunger slowly pushed again. If significant resistance is still encountered, it may be necessary to pull the needle entirely out of the injection site and try again in a new position. If significant resistance continues to persist, it may be necessary to try a different injection needle. If this is not successful, replace the syringe and injection needle.
9. Used and partially used syringes and used injection needles could be biohazardous and should be handled and disposed of in accordance with facility medical practices and local, state, or federal regulations.

Note: PROLARYN GEL and PROLARYN PLUS have a lower injection force if warmed and, therefore, may flow more easily through the transoral needle.

See percutaneous vocal fold injection guidelines