Development and first data of a customized short tracheal cannula based on digital data

Area of Science:

• Medical Devices
• Biomaterials
• Surgical Technology

Background:

• Commercially available stoma buttons often have inadequate margin fit.
• Tracheal cannulas are crucial for post-laryngectomy airway management.
• Digital data offers potential for personalized medical device design.

Purpose of the Study:

• To develop a customized short tracheal cannula using digital data.
• To evaluate silicone as a material for tracheal cannulas, considering germ colonization.
• To assess appropriate cleaning procedures for the new cannula.

Main Methods:

• Computed tomography scans from 53 laryngectomy patients were analyzed.
• A custom silicone tracheal cannula was designed and manufactured.
• The cannula was tested in 10 patients for 4 weeks, with clinical and microbiological assessments.

Main Results:

• The customized cannula demonstrated successful incorporation in all patients without irritation or mucosal lesions.
• Patient subjective assessments were promising, with suggestions for improvement noted.
• Silicone cannulas showed higher germ colonization than silver, but effective chemical and mechanical cleaning methods were confirmed.

Conclusions:

• A viable workflow for creating customized tracheal cannulas from digital data was established.
• The developed cannula is compatible with existing equipment and standard cleaning protocols.
• Further clinical studies are necessary to confirm the benefits for patients.