Our client, Dr. Kaufman, saw an urgent clinical need to train healthcare providers to respond to tracheostomy complications, some of which require immediate life-saving intervention. He searched the internet hoping to find a stock model for tracheostomy complication training but found nothing. He did find Pulse MDM. Dr. Kaufman, a critical care medicine specialist, is an atypical client for Pulse MDM. Our clients are medical device professionals interested in testing, training, and marketing new medical procedures and devices. However, our process remained consistent with our other clients. Dr. Kaufman outlined five of the most important complications that arise from tracheostomy tubes. He described the clinical complexities of each along with the anatomical features required to complete effective training, and we were able to begin conceptualizing a model to solve his problem.

Pulse MDM designed a model with a singular mouth, tongue, and neck, along with four modular tracheas. Each of these represents a unique clinical complication.  The four trachea assemblies plug into the model neck from the back and are held securely with a clip and magnets to easily switch between tracheas. The model is reusable and precludes the need for biohazard permissions that are required for ex-vivo tissue models.

As a clinician, Dr. Kaufman is very a hands-on person. He made a few trips from NYC to the Pulse MDM’s Bucks County PA model studio to guide us toward the most clinically accurate shape and functions. Pulse MDM digitally sculpted the complex anatomy for Dr. Kaufman’s review and approval.  Mechanical features were added for assembly and ease of use. The final prototype parts are fabricated from tissue like soft rubber and acrylic.

Lower face and neck– The lower face and neck model include the proximal portion of the esophagus, an open mouth, a soft tongue, a tracheostomy stoma, and unbreakable teeth.  From the back side of the model, the trachea model variations can be swapped out. They snap into position and are held securely with a clip and magnets.

Trachea Inserts:
New Tracheostomy/Acute– Right after surgery, the tissue tract between the skin and the trachea takes time to heal. If the freshly placed tracheostomy tube becomes displaced, it can easily move into a false passage (located in the space in front of the trachea) instead of in the trachea. This leads to respiratory distress and must be immediately managed by the clinician. Similar to the real clinical scenario, this model allows for oro-tracheal intubation. Attempts at placing a tracheostomy tube into the fresh stoma would usually be unsuccessful in real life as well as in our model.

Healed Tracheostomy/Chronic– In a healed tracheostomy, the tissue between the skin and the trachea is connected.  The clinician can get a feeling of the typical trach tube insertion and compare how it feels with a new/acute tracheostomy.

Total Laryngectomy– In general, if the tracheostomy tube comes out and cannot be quickly replaced, clinicians may be required to intubate the patient. However, if the patient has a total laryngectomy, intubation through the mouth is not possible as the opening at the top of the trachea is surgically blocked off.  The model provides help to train clinicians on how to diagnose and restore the airway for a total laryngectomy.

Tracheo-Innominate Fistula– Chronic patients can sometimes experience a trachea innominate fistula, which is when the tracheostomy tube rubs through the anterior wall. This can result in blood entering the trachea and lungs which causes a critical airway event for the patient. The Pulse MDM model includes an innominate artery that bleeds.

Although this custom model is not available for sale to the public, we are delighted to make you a version that is specific to your unique medical device and procedure. Please use this link to start the process of receiving a model concept; a visual representation of how clinicians and patients will experience your product and procedure. Pulse MDM does not charge for model concepts or the conversations around them so there is no risk to see how we can help you to tell your story in the most engaging and memorable way possible.