Description
The Blom-Singer® Voice Prosthesis Placement Surgical Kit is designed to be used during surgery for primary or secondary placement of a tracheoesophageal puncture and voice prosthesis. This medical device may be used only once with one patient. It may not be reused. It is designed to be used with Blom-Singer® Classic™ indwelling voice prosthesis.
- Kit is comprised of three single-use surgical instruments: A 13ga curved trocar fitted with a 9ga sheath which allows for approximation of the party wall thickness as the puncture is completed, a pharynx protector fitted with a handle and notch to protect the posterior esophageal wall, and a dilating catheter.
- Three-sided non-coring trocar: The 13ga trocar is solid body faceted to make a surgical incision. The distal end of the curved trocar is attached to a handle to ensure a secure leveraged grip to penetrate fibrous tissue. A 9ga sheath acts as a trocar cover. The colored bands on the sheath act as a voice prosthesis sizing guide.
- Gradual dilating catheter: The flexible dilating catheter is tapered along its length. As it is pulled in an anterograde motion through the tracheoesophageal puncture, the catheter will dilate the puncture as it increases in diameter.
- Sterile.
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