The tracheostomy surgical procedure opens a direct airway through an incision in the trachea. Percutaneous tracheostomies are usually performed to create long-term ventilation, for example in comatose patients or for those who are undergoing surgery to the head and neck.
Percutaneous dilational tracheostomy (PDT) was first pioneered by Dr Pasquale Ciaglia in 1985. In 1990 the first Ciaglia percutaneous tracheostomy introducer set with sequential dilators was introduced. In 1999, the Ciaglia Blue Rhino single dilator tracheostomy device came on the market.
Cook Medical has now launched the Ciaglia Blue Dolphin Balloon percutaneous tracheostomy introducer, which represents the second generation of Cook's tracheostomy devices, says Cook Medical product manager Dr Michael Billado
So why has this simple idea which claims to reduce time and costs for users, and most significantly risk to patients, taken so long to develop? The answer may lie in the length of time new technologies and techniques take to be adopted and accepted across the spectrum of medical disciplines. Billado says some health practitioners are unnecessarily using techniques that are ten to 15 years old.
The 5.4cm-long Blue Dolphin, made from nylon, has an outer diameter of 16mm when fully inflated. The maximum inflation pressure of the balloon is 11 atmospheres (atm). The device takes ideas from the Rhino, improving it "significantly", says Billado.
"The key is the inflation device, which allows to get up to a higher pressure or higher to dilate the stomal tract. "The traditional devices have a tendency to go too far and perforate the tracheal rings," says Billedo. "With this you create a very small opening with a needle and do a pre-dilation with a catheter, before the Blue Dolphin goes in."
The idea to transfer the balloon dilation technique to tracheostomy procedures was not developed until the company began working with Dr Michael Zgoda, a US-based fellow in pulmonary medicine at Carolinas Medical Center in North Carolina, in 2004.
No tissue dilation is required beyond a simple skin incision and no dilator is repeatedly advanced back and forth into the trachea. The Blue Dolphin reduces patient risks such as bleeding, ring fractures and posterior wall perforations.
The one-step procedure also reduces the time taken to carry out the tracheostomy, eliminating the need for transportation from the operating theatre or from the intensive care unit.
Zgoda's specific goal was to decrease the likelihood of posterior wall trauma during placement and damage to the structures around the anterior trachea, to ensure a safer technique.
While the tracheostomy procedure is on the whole considered safe, as with all surgical procedures problems can occur. One of the most common complications is tracheal damage. Immediate problems can occur from injury to great vessels or recurrent laryngeal nerves, which can cause bleeding from divided thyroid isthmus.
Other complications such as secretions and mucus plugging, dislodged tube, respiratory arrest and post-obstructive pulmonary edema can also occur early in the procedure. Arguing that the Blue Dolphin device is safer for patients than traditional techniques, Billado says the balloon dilation technique has "always seemed logical in performing this operation".
The Blue Dolphin Balloon has so far been tested by clinicians in the US and Europe and has received praise from numerous quarters, according to Cook.
The device, currently in second-launch phase, is soon to be rolled out across all disciplines performing percutaneous tracheostomies.