Customized Tracheocutaneous Fistula and Tracheostomy Plug

A mold-based method of manufacturing a tracheocutaneous fistula and tracheostomy plug, the method comprising:

• measuring a minimum stoma diameter;
• measuring a stoma length;
• creating a virtual 3D mold for the plug having a virtual negative space for
• a face plate having a face plate diameter greater than the minimum stoma diameter, and
• a body having a first end connected to the first plate and a second end, a shoulder connected at the second end, and a tapered tip extending from the shoulder, wherein the body has a length extending from the first end to the second end that is equal or substantially equal to the stoma length and a shoulder diameter that is greater than the minimum stoma diameter;
• manufacturing a physical mold having a physical negative space equivalent to the virtual negative space of the virtual 3D mold;
• filling the physical negative space of the physical mold with a mold material to form the plug;
• and
• allowing the mold material forming the plug to cure.

A direct method of manufacturing a tracheocutaneous fistula and tracheostomy plug, the method comprising:

• measuring a minimum stoma diameter;
• measuring a stoma length;
• creating a virtual 3D plug model, the virtual 3D plug model having
• a face plate having a face plate diameter greater than the minimum stoma diameter, and
• a body having a first end connected to the first plate and a second end, a shoulder connected at the second end, and a tapered tip extending from the shoulder, wherein the body has a length extending from the first end to the second end that is equal or substantially equal to the stoma length and a shoulder diameter that is greater than the minimum stoma diameter;
• manufacturing the plug from the virtual 3D plug model using additive manufacturing.