Percutaneous
injection guidelines^1,2

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

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

1. Prepare the syringe(s) of PROLARYN GEL or PROLARYN PLUS, injection needle(s), and nasopharyngoscope 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. In all circumstances, when the injection needle is attached to the syringe of PROLARYN GEL or PROLARYN PLUS, the needle must be tightened securely to the syringe and be primed with PROLARYN GEL or PROLARYN PLUS. Prepare nasopharyngoscope equipment using facility medical practices for a nasopharyngoscope examination.

   
   PERCUTANEOUS NEEDLE
   1.5'', 25-gauge

   
   PERCUTANEOUS NEEDLE TIP
   Noncoring Huber point

2. Remove foil pouch from the shipping box. 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.
3. Prepare patient for nasopharyngoscopy and anesthetize using standard methods. No anesthesia is required but may be utilized at the PROLARYN PLUS injection site.
4. Remove the Luer syringe cap (on the distal end of the syringe) prior to attaching the needle. The injection needle can then be twisted onto the Luer lock fitting of the syringe. The needle must be tightened securely to the syringe and be primed with PROLARYN GEL or PROLARYN PLUS. Slowly push the syringe plunger until PROLARYN GEL or PROLARYN PLUS extrudes from the end of the 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 needle.
5. Place the nasopharyngoscope to precisely visualize needle position and volume of PROLARYN GEL or PROLARYN PLUS during augmentation.
6. Extend the patient’s neck if possible and identify by external landmark the cricoid and inferior border of the thyroid cartilage and thyroid notch. Because the superior surface of the vocal fold lies at approximately half the distance between the superior notch and the inferior border of the thyroid cartilage, injection is placed below this level but above the inferior thyroid cartilage margin. Transcartilaginous injection is used unless cartilage calcification prevents it, in which case needle placement is through the cricothyroid membrane.
   NOTE: Do not inject into a blood vessel.

   
   LOCATION AND DIRECTION OF
   NEEDLE PLACEMENT FOR
   PERCUTANEOUS INJECTION

7. PROLARYN GEL or PROLARYN PLUS should be injected lateral to the thyroarytenoid muscle. With needle location visually confirmed through the nasopharyngoscope, slowly push the plunger shaft of the syringe to start the injection. PROLARYN GEL or PROLARYN PLUS is injected in a sublamina proprial plane. 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 respiration 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 shaft, the injection needle should be pulled back about one (1) to three (3) millimeters (with the needle still in the vocal fold tissue) and the plunger shaft 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 transoral vocal fold injection guidelines