About Laryngeal Umbrella Keel
Laryngeal Umbrella KeelThe Laryngeal Umbrella Keel is a medical device used in the treatment of various laryngeal conditions. It is designed to prevent stenosis following a hemilaryngectomy and to aid in the formation of a sharp anterior commissure. Here are some key points about the Laryngeal Umbrella Keel:
- Purpose: The keel is used following repair of stenosis or removal of the Montgomery Laryngeal Stent to help form a sharp anterior commissure and prevent stenosis.
- Material: It is typically made of silicone rubber, which is inert and ensures re-epithelialization of incised tissue.
- Design: The keel consists of a flexible extralaryngeal portion and a flexible keel portion that extends through the anterior commissure.
- Function: The extralaryngeal portion covers the thyrotomy repair and is sutured to the thyroid laminae, while the keel portion helps maintain the sharpness of the anterior commissure.
- Safety: The device is MRI safe and does not contain natural rubber latex.
- Usage: It is intended for single-use and requires a prescription.
- Manufacturer: The Laryngeal Umbrella Keel is manufactured by E. Benson Hood Laboratories.
- Regulation: The device has an FDA premarket submission number of K841348 and is classified under the FDA product code FWN, which stands for Prosthesis, Larynx.
- Availability: It is commercially available and distributed by E. Benson Hood Laboratories.
- Clinical Use: The keel is beneficial in preventing the recurrence of anterior glottic stenosis after surgical correction, ensuring a more complete closure of the anterior commissure to minimize laryngeal secretions into the extralaryngeal spaces.
Optimized for Safe and Effective Laryngeal SupportThis umbrella-shaped laryngeal keel is expertly designed to provide gentle, comprehensive support during ENT procedures. Its atraumatic, flexible edges and medical grade silicone composition allow for smooth, safe insertion, minimizing tissue irritation. The radiopaque feature ensures clinicians can monitor its position through X-ray, enhancing surgical precision and patient safety.
Convenience: Ready-To-Use and Single Use DesignSupplied sterile and latex-free, the Laryngeal Umbrella Keel is intended for convenient single-use applications. This approach eliminates the need for reprocessing, lowers infection risks, and meets the highest standards for modern surgical environments. Lightweight and portable, it's ideal for efficient implementation in ENT settings throughout India.
FAQ's of Laryngeal Umbrella Keel:
Q: How is the Laryngeal Umbrella Keel used during ENT surgeries?
A: The Laryngeal Umbrella Keel is manually inserted to support the larynx and vocal cords, helping to prevent web formation and maintain airway patency after surgical procedures. Its design suits standard laryngeal anatomical structures, and radiopacity allows verification of placement with X-ray.
Q: What benefits does the umbrella-shaped design offer?
A: The umbrella-shaped profile ensures broad, stable tissue support with flexible, atraumatic edges that minimize local irritation. This helps promote proper healing and reduces the risk of adhesions or trauma compared to traditional implants.
Q: When should I use a new keel from the sterile packaging?
A: A new Laryngeal Umbrella Keel should be used fresh from its sterile packaging immediately before surgery. The product is designed for single use only, reducing infection risk and eliminating the need for sterilization between procedures.
Q: Where should the keel be stored before use?
A: Store the Laryngeal Umbrella Keel in a cool, dry location away from direct sunlight to maintain its sterility and material integrity. Following the recommended storage instructions will help preserve its shelf life of up to five years.
Q: What is the process for inserting the Laryngeal Umbrella Keel?
A: Manual insertion of the keel is performed following standard ENT surgical protocols. Its flexible, smooth edges facilitate easy placement, and being radiopaque, its location can be confirmed using X-ray imaging post-insertion.
Q: What makes this product suitable for patients with latex allergies?
A: Crafted from medical grade silicone and being completely latex-free, the Laryngeal Umbrella Keel greatly reduces allergic reactions, making it a safe option for patients with known latex sensitivities.