Hiatal Hernia Repair and GERD Custom Model

The Challenge:

The training aid for the treatment of GERD using a small flexible band at the lower end of the esophagus the client was using prior to contacting Pulse MDM was a very basic silicon model of the esophagus and partial stomach placed in a plastic box. This makeshift model could only be used to practice device size selection.  Otherwise, cadavers were used for surgical training.  What the client wanted was for Pulse MDM to create a clinically accurate, portable, and professional-looking model to train surgeons to treat hiatal hernia and GERD with the client’s unique device.  This is, of course, not an “off-the-shelf” item.

 

Model Design:

The must-have specification included a crural defect, esophagus, stomach, diaphragm, liver, and vagus nerve as it runs posterior to the esophagus.  The abdomen is shaped in a permanently insufflated position with the posterior portion removed to easily see the targeted anatomy without the need for cumbersome visualization equipment.   The esophagus can be set to replicate a hiatal hernia and pulled down to its’ proper position during the training. All the organs were planned to be realistically soft except for the diaphragm and outer skin.  These parts were rigid to provide structure and to fixture the other organs in place.

 

Model Development:

They say, “the devil is in the details,” and as always, they are right!  Great care was taken to work with our client’s clinical team to make sure the crural defect was in the exact location, that the rigid diaphragm would not obstruct instrument access, the gastroesophageal (GE) junction diameter was optimal for their device measurement training, and that the liver was soft enough to be easily retracted.

In addition to aligning the vagus nerve properly, during the development process, we developed a way to locate the vagus nerve proximal to the esophagus before the procedure and have the surgeon “dissect” it away during the procedure.  Afterward, the vagus nerve is easily and without replacing any components, reset it back to its proximal position. The clinical team evaluated several model iterations to guide us in determining port locations for optimal instrument angles to reach the targeted anatomy.

 

Model Solution:

The model provides the clinical scenario to demonstrate surgical technique without the use of a cadaver, enabling the practice of measuring and placing the client’s device at the lower esophageal sphincter (LES). The surgeons can pull the hiatal hernia back into the abdomen, mobilize the esophagus, identify the LES, dissect between the posterior esophagus and posterior vagus nerve, laparoscopically match the device to the esophageal diameter, place the device through the dissected eyelet at the posterior esophagus and complete the necessary fit adjustments.  The window in the abdomen precludes the need for expensive and bulky visualization equipment, making it even more convenient to train in the field.

Our client eliminated cadaver labs and all the associated costs of travel, logistics, and disposal, resulting in huge savings.

Our client hosts training in any setting, any country, and any facility.

Our client enjoys the ability to reuse their instrumentation and implants after training, as models are always clean and ready to go.

 

Following the delivery of the model, a senior manager of professional education for the client reported:

“Before Pulse MDM: there’s a gap between the training and the hands-on experience for surgeons,

After using the Pulse MDM model: Reps are able to utilize trainings to provide hands-on experience in the field.”

Sr manager professional education

 

Although this custom model is not available for sale to the public, we would be 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 in seeing how we can help you to tell your story in the most engaging and memorable way possible.

Gastroesophageal Reflux Disease (GERD)  Overview:

Gerd is a condition when stomach acid travels up the esophagus from the stomach.  This occurs when the lower esophageal sphincter is weak.  This backwash of stomach acid can irritate the esophagus lining.  GERD is treated with antacids, various acid-preventing medications, and therapies or with surgery.  It is possible this disease is associated with a hiatal hernia.

 

Hiatal Hernia Overview:

A hiatal hernia is a condition where the superior portion of the stomach protrudes through an opening in the diaphragm where the stomach attaches to the esophagus.  The above model procedure helps prevent GERD with a flexible ring placed around the esophagus just above the stomach during a minimally invasive procedure.

 

LINX Reflux Management System