Overview

Clinician-inspired solutions

Shiley™ neonatal and pediatric tracheostomy solutions incorporate a wide range of simple and smart design advances to improve the healthcare experience for both patients and clinicians.

Our portfolio offers innovative cuffed and cuffless options, in a variety of sizes, with designs tailored to the needs of neonatal and pediatric patients.

These clinician-inspired solutions include:

  • Flange distinction for neonatal or pediatric patients
  • A unique pediatric cuff design
  • Comfort recess on the bottom of the connector to help reduce inferior stoma irritation
  • Transparent soft flange that supports patient comfort and visualization of the skin below
  • Softer material and expanded size options, compared to previous Shiley™ tracheostomy products

To help clinicians manage ventilator-dependent patients, the low-profile, low pressure TaperGuard™ cuff on the Shiley™ neonatal and pediatric tracheostomy tubes:

  • Reduces fluid leakage by an average of >94.8% at similar or lower intracuff pressure.([FOOTNOTE=Internal bench testing. Comparative fluid seal test performed using the Shiley™ 4.0PCF and 6.5PLCF pediatric tracheostomy tubes with taper-shaped cuff vs. predicate Shiley™ 4.0PDC and 6.5PLC pediatric tracheostomy tubes with barrel-shaped cuff.],[ANCHOR=],[LINK=])
  • Significantly improves management of airway leak at pressures below 25 cm H2O([FOOTNOTE=Internal bench testing. Comparative ventilator air leak test performed using the Shiley™ 4.0PCF and 6.5PLCF pediatric tracheostomy tubes with taper-shaped cuff vs. predicate Shiley™ 4.0 PDC and 6.5PLC pediatric tracheostomy tubes with barrel-shaped cuff.],[ANCHOR=],[LINK=])
  • Reduces removal force by 58.3% compared to the previous barrel-shaped cuff — reducing the potential for stoma irritation or damage during removal.([FOOTNOTE=Internal bench testing. Comparative removal force test performed using the Shiley™ 4.0PCF and 6.5PLCF Pediatric Tracheostomy Tubes with taper-shaped cuff vs. the predicate Shiley™ 4.0PDC and 6.5PLC pediatric tracheostomy tubes with barrel-shaped cuff.],[ANCHOR=],[LINK=])

These products are manufactured with a non-DEHP plasticizer. This new material has been incorporated into the soft, transparent flange that allows for enhanced visualization of the underlying skin and stoma site.

Features

Clinician-inspired solutions that meet patient-specific needs

Non-DEHP material

  • Shiley™ tracheostomy solutions meet the latest safety standards*, offering tubes that are manufactured with a non-DEHP plasticizer material.

Soft, clear neck flange

  • The Shiley™ tube's transparent flange allows for enhanced visualization of the underlying skin and stoma site.

Varying flange angles

  • Shiley™ tracheostomy solutions are manufactured with varying flange angles to help provide a better fit for infants and children as they grow.

Comfort recess

  • Shiley™ tracheostomy tubes include a comfort recess designed to help reduce pressure on the patient’s skin.

Tape tie recess

  • The flange on a Shiley™ tracheostomy tube includes a recess to make insertion of a tape tie or tracheostomy tube holder simple and to reduce contact with the patient's skin.

TaperGuard™ low-profile, low-pressure cuff

  • Provides sealing through a low-profile (low-volume), low-pressure air-filled cuff.1
  • Reduces removal force by 58.3% compared to traditional high volume low pressure cuffs, thereby reducing the potential for stoma irritation during removal.1
  • Reduces fluid leakage by an average of 94%, in comparison to the predicate Shiley™ device at 20% lower intracuff pressure than predicate Shiley™ device.3

Child-safe pilot balloon

  • Includes plastic housing around the tip of the inflation lumen that prevents the ability of placing the inflation lumen into the 15 mm connector of the tracheostomy tube, which could obstruct airflow.

Order Information

  • Pending 510K approval

  • *As of European product introduction in 2013.