Cook Medical Evolves Percutaneous Tracheostomy Procedures with the Launch of Ciaglia Blue Dolphin

Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates minimally invasive medical device design, biopharma, gene and cell therapy, and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics.

    * Ciaglia Blue Dolphin is the world's first one-step device for percutaneous tracheostomy that combines balloon dilation and tracheal tube insertion.
    * Smooth transition from dilation to tube insertion minimises airway leakage while optimising patient ventilation.
    * This expert-led product innovation will increases the ease of performing percutaneous tracheostomy procedures.
    * The Ciaglia Blue Dolphin has been specifically designed to decrease the risk of the three most common immediate complications of percutaneous tracheostomy (PCT): bleeding, tracheal ring fracture and posterior wall injury.
    * Percutaneous tracheostomy is a well-established procedure in adult intensive care medicine. The device is new and evolutionary, the procedure is not.

“We've been using Blue Dolphin and have found it very simple and easy to use. It's a natural evolution for tracheostomy devices. The Blue Dolphin needs minimal force when inserting the tube, whilst placement accuracy is enhanced. Ultimately, Blue Dolphin offers a true one-step technique,” comments Dr. Jeff Phillips, Clinical Lead and Consultant in Intensive Care Medicine at Princess Alexandra Hospital in Harlow, Essex.

“Since 1987, we have worked with innovative physicians and surgeons to improve the safety, economy and convenience of this popular procedure. By introducing Blue Dolphin, we've produced a device that simplifies tracheostomy procedures. Its beauty lies in its simplicity: It's intuitive to use and is a simple and fast way to perform safe percutaneous tracheostomy procedures. It's effective for the intensivist or anaesthetist and reduces risks to the patient,” comments Bruce Gingles, Global Vice President of Cook Medical's Critical Care strategic business unit.

    * Dr. Jeff Phillips, Clinical Lead and Consultant in Intensive Care Medicine at Princess Alexandra Hospital in Harlow, Essex—Image and Biography
    * Bruce Gingles, Global Vice President of Cook Medical's Critical Care strategic business unit—Image and Biography
    * Ciaglia Blue Dolphin Image

Limerick, Ireland, 10 September 2008 – Cook Medical today launches the Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer—the world's first one-step device for percutaneous tracheostomy procedures. Ciaglia Blue Dolphin minimises patient risk by combining balloon dilation and tracheal tube insertion. The first device that offers a one-step solution for elective tracheostomies, Ciaglia Blue Dolphin has been specifically designed in collaboration with experts in Critical Care medicine to decrease the risk of the three most common and immediate complications of percutaneous tracheostomy (PCT): bleeding, tracheal ring fracture and posterior wall injury.

Percutaneous tracheostomies are generally performed when there is the need for long term ventilation, for example in comatose patients and in those who are undergoing surgery to the head and neck. While PCTs are commonly reserved for elective tracheostomies in which procedure duration isn't an issue, any potential reduction in procedure time is welcome when operating on a critically ill patient. Currently percutaneous tracheostomy is accepted as a safe and reliable bedside procedure; however, the potential for intraoperative complications such as tracheal damage still exists. By creating a one-step device from insertion to ventilation Cook's Ciaglia Blue Dolphin further reduces that potential.

Other potential benefits of the Ciaglia Blue Dolphin include: ease of use for the operator and reduced airway leakage, because there is no need to change from a dilator to loading obturator and tracheotomy tube assembly, as well as optimised procedure times and reduced pressure on the anterior tracheal wall, due to the balloon's radial dilation qualities.

Dr. Jeff Phillips, Clinical Lead and Consultant in Intensive Care Medicine at Princess Alexandra Hospital in Harlow, Essex, comments, “We've been using Blue Dolphin and have found it very simple and easy to use. It's a natural evolution for tracheostomy devices. The Blue Dolphin needs minimal force when inserting the tube, whilst placement accuracy is enhanced. Ultimately, Blue Dolphin offers a true one-step technique.”

Made from nylon, the Blue Dolphin balloon is 5.4 cm long and has an outer diameter of 16 mm when fully inflated. The maximum inflation pressure of the balloon is 11 Atmospheres (ATM). It uses an antegrade approach with the balloon providing outward radial dilation. Because in most cases no soft tissue dissection is needed beyond a simple skin incision and no dilator is repeatedly advanced back and forth into the trachea, it reduces the patient risk associated with bleeding, ring fractures and posterior wall perforations.

The procedure time from tracheal puncture to tracheotomy tube placement stands at about 4 to 6 minutes. Once the procedure is completed, because of tissue ‘elastic memory’, the stoma tightly collapses back around the tracheotomy tube within a minute or so, providing the needed seal and tamponade effect to help prevent any bleeding.

Bruce Gingles, Global Vice President of Cook Medical's Critical Care strategic business unit, says, “Since 1987, we have worked with innovative physicians and surgeons to improve the safety, economy and convenience of this popular procedure. By introducing Blue Dolphin, we've produced a device that simplifies tracheostomy procedures. Its beauty lies in its simplicity: It's intuitive to use and is a simple and fast way to perform safe percutaneous tracheostomy procedures. It's effective for the intensivist or anaesthetist and reduces risks to the patient.”

Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates minimally invasive medical device design, biopharma, gene and cell therapy, and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Founded in 1963 and operated as a family-held private corporation, Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com .