Enhancing Patient Care and Clinical Efficiency with Provox Dilator

The management of tracheoesophageal punctures (TEPs) is a critical component of post-laryngectomy voice rehabilitation, requiring precise instruments to ensure optimal outcomes during routine voice prosthesis (VP) replacement and in addressing complications such as leakage, voicing difficulties, or TEP issues.

The Provox Dilator is uniquely engineered to ensure complete and consistent tract dilation—both anterior and posterior—for ease of voice prosthesis (VP) replacement unlike other dilators. This full-section length dilation helps eliminate one of the most common yet overlooked barriers to successful TEP placement: an inadequately dilated tract. By providing consistent dilation to the correct Fr size throughout the entire TE tract, the Provox Dilator supports smoother prosthesis exchanges, enables up- or down-sizing of the voice prosthesis, and helps maintain TEP patency even in cases of tract stenosis. It’s a simple, reliable solution that addresses a critical clinical challenge.

You asked, we listened. In response to the growing demand for single-use instruments, Provox Dilator is designed for one-time use—enhancing procedural efficiency and cost by eliminating reprocessing, reducing the risk of cross-contamination, and streamlining clinical workflow. Its tapered design allows for gradual dilation from 15 Fr to 24 Fr, with incremental ring markings that provide visual and tactile feedback for each 2–3 Fr step. The Provox Dilator maintains consistent tract dimensions, improving the success of voice prosthesis placement. The incremental rings also help prevent slippage during the procedure. To identify the diameter currently within the tract, clinicians can count backward from the medallion end—starting at 24 Fr—progressing through 22 Fr, 20 Fr, 18 Fr, and down to 15 Fr.

Clinical Scenarios

1. Using Provox Dilator to minimize aspiration and facilitate prosthesis placement

Following removal of a voice prosthesis, patients are at risk of aspirating esophageal contents through the tracheoesophageal (TE) tract. To reduce this risk, the Provox Dilator can be inserted immediately after prosthesis removal to temporarily stent the tract and minimize aspiration of secretions.

The dilator should be inserted with the curvature directed downward and advanced until the desired diameter is reached. Although the incremental rings help prevent the dilator from slipping out of the tract, the medallion may be secured to the skin with tape for added stability. Dilating the tract to a size approximately 2 Fr larger than the intended prosthesis can ease the placement of both the sizer and the final device. After sizing, the dilator may be reinserted while the clinician prepares the voice prosthesis in the insertion system or capsule.

Clinical tips:

• Keep a water-soluble lubricant readily available (e.g. K-Y jelly, Surgilube or Xylocaine [lidocaine] jelly)
• Dilate the TE tract to 2Fr larger than the intended prosthesis size, if clinically appropriate, to ease prosthesis placement
• Allow additional time for dilation in patients with less compliant tissue
• Maintain easy access to the dilator during TEP assessment and voice prosthesis replacement in case re-stenting is needed
• Secure the medallion to the skin with medical tape to prevent displacement
• When removing the dilator, gently pull from the rod, not the medallion
• Document the patient's response to dilations, amount of dilation required, duration of dilation, and any observation that may inform future prosthesis replacements

2. Managing dislodged or partially dislodged voice prostheses

A voice prosthesis may become either fully or partially dislodged within the tracheoesophageal (TE) tract. In cases of complete dislodgement, there is a risk that the tract may begin to stenose or even close entirely, depending on the maturity of the tract and the tissue integrity. Prompt stenting is essential once dislodgement is identified to preserve tract patency.

If the patient presents to clinic with an open tract, the Provox Dilator can be inserted to preserve patency and dilate the tract if the TEP has stenosed. The tip of the dilator is 15 Fr and allows for gradual dilation until the tract reaches the appropriate diameter for prosthesis placement.

In cases of partial dislodgement, the anterior and posterior aspects of the tract may differ in diameter. This can result in symptoms such as difficulty or absent voicing, challenges with cleaning the prosthesis (i.e., brush cannot be inserted fully, pain/discomfort with cleaning, blood on the brush when cleaning), inflamed tissues, and changes in swallowing. If the prosthesis is displaced posteriorly, the anterior flange may be difficult to visualize. Conversely, anterior displacement may present with a fully visible tracheal flange, but the esophageal flange is embedded with the TEP. Once the dislodged prosthesis is removed, the Provox Dilator can be used to re-establish uniform tract dimensions and facilitate placement of a new prosthesis.

Clinical tips:

• Instruct patients on how to stent the TE tract at home if dislodgement occurs
• Review emergency procedures during rehabilitation sessions
• Provide written instructions outlining steps to take if the prosthesis becomes dislodged at home
• Educate patients on the signs and symptoms of a partially dislodged prosthesis
• Reinforce this education regularly throughout the rehabilitation process

3. Increasing voice prosthesis diameter

A larger diameter voice prosthesis may be clinically indicated r to reduce speaking effort or to address early leakage by placing a device with a higher opening pressure (ie. Provox Activalve). For example, if a patient presents to the clinic with the goal of achieving easier voicing to facilitate socializing with friends and family, the clinician may consider upsizing the diameter of the voice prosthesis after completing comprehensive evaluation. The assessment should include ruling out other factors that impact voicing such as dysphagia, discoordination of respiration and speech, inadequate seal with current stomal attachment, a voice prosthesis that is too long and abutting the esophageal wall, or the presence of granulation tissue.

If the determination is that a larger diameter voice prosthesis is appropriate (ie. transitioning from a 17Fr Vega to a 20Fr Vega), Provox dilator can be used to slowly dilate the tract from 17Fr to either 20Fr or 22Fr to facilitate placement. Dilating 2Fr larger than the prosthesis that will be placed can ease placement of the voice prosthesis.

A common question is the duration of the dilation process, which varies on a case-by-case basis. This is highly dependent upon tissue compliance and other patient factors. For some patients, the tract will dilate quickly (i.e. 15 minutes) or for other patients, the dilation may take several hours. Below are some clinical tips to allow for sufficient time for gradual dilation and help manage patient expectations.

Clinical tips:

• Inform the patient that the appointment may take longer than usual
• Begin dilation early in the day to allow flexibility in timing
• Monitor the patient periodically during dilation
• Document the duration and response to dilation for future reference

4. Managing an over-dilated TE tract

In some cases, the tracheoesophageal (TE) tract may become inadvertently over-dilated during a medical procedure or after a dislodgement, which results in a tract diameter that exceeds the size of the previously placed voice prosthesis. The Provox Dilator can be inserted at a smaller diameter to encourage gradual stenosis of the tract around the dilator.

To assess whether the tract is beginning to stenose, the clinician can evaluate the resistance of the dilator during gentle manipulation and check for leakage around the device by administering a small sip of water. As noted in previous sections, this process may take several hours, and in some cases, the tract may not return to its original diameter

The Provox Dilator is a clinically versatile and practical tool designed to meet the complex demands of tracheoesophageal puncture (TEP) management. In addition to its clinical utility, there may be reimbursement considerations associated with its use. For example, HCPCS code L8514 (Tracheoesophageal puncture dilator; replacement only) may be applicable. Clinicians are encouraged to consult with their billing and coding departments to determine the appropriateness and accuracy of using this code in accordance with payer guidelines and institutional policies.

References:
1. Provox Voice Prosthesis LitReview; cited 2024-04-10. Available from: https://www.atosmedical.com/healthcare-professionals/clinical-evidence
2. Hancock K, Ward E, Lawson N, As-Brooks CJ. A prospective, randomized comparative study of patient perceptions and preferences of two types of indwelling voice prostheses. Int J Lang Commun Disord. 2012;47(3):300-9.
3. Ward EC, Hancock K, Lawson N, van As-Brooks CJ. Perceptual characteristics of tracheoesophageal speech production using the new indwelling Provox Vega voice prosthesis: a randomized controlled crossover trial. Head Neck. 2011;33(1):13-9.
4. Hilgers FJ, Ackerstaff AH, Jacobi I, Balm AJ, Tan IB, van den Brekel MW. Prospective clinical phase II study of two new indwelling voice prostheses (Provox Vega 22.5 and 20 Fr) and a novel anterograde insertion device (Provox Smart Inserter). Laryngoscope. 2010;120(6):1135-43.
5. Hilgers FJ, Ackerstaff AH, van RM, Jacobi I, Balm AJ, Tan IB, et al. Clinical phase I/feasibility study of the next generation indwelling Provox voice prosthesis (Provox Vega). Acta Otolaryngol. 2010;130(4):511-9.
6. Serra A, Spinato G, Spinato R, Conti A, Licciardello L, Di Luca M, et al. Multicenter prospective crossover study on new prosthetic opportunities in post-laryngectomy voice rehabilitation. J Biol Regul Homeost Agents. 2017;31(3):803-9.
7. Kress P, Schäfer P, Schwerdtfeger F-P, Roesler S. Measurement and comparison of in vitro air-flow characteristics of the most frequently used European indwelling voice prostheses types. 2007.
8. Grolman W, Eerenstein SE, Tange RA, Canu G, Bogaardt H, Dijkhuis JP, et al. Vocal efficiency in tracheoesophageal phonation. Auris Nasus Larynx. 2008;35(1):83-8.
9. Parrilla C, Longobardi Y, Galli J, Rigante M, Paludetti G, Bussu F, Scarano E. Periprosthetic Leakage in Tracheoesophageal Prosthesis: Proposal of a Standardized Therapeutic Algorithm. Otolaryngol Head Neck Surg. 2021 Sep;165(3):446-454. doi: 10.1177/0194599820983343. Epub 2021 Jan 5. PMID: 33400627.