MDEA Winner Pleuraflow Poised to Make a Difference

MDEA Winner Pleuraflow Poised to Make a Difference

PleuraFlow Active Tube Clearance System, developed by Clear Catheter Systems, Carbon Design Group, and Xeridiem Medical Devices, has been awarded a 2011 Medical Design Excellence Award. PleuraFlow presents an innovative design and engineering solution to a decades old problem of maintaining clear chest drainage after heart or lung surgery. The blood clotting that saves our lives after injury, can mask blood loss or infection after surgery. As the first chest tube with a mechanism for actively clearing blood clots, the PleuraFlow Active Tube Clearance System represents the most significant innovation in chest tubes in half a century.

The PleuraFlow Active Tube Clearance System was developed to clear blood clots from chest tubes. The body's natural response to injury is to form clot. Unfortunately, the body can't distinguish between injury and life-saving surgery. After heart or lung surgery, chest tubes are installed to drain fluids or air from the chest cavity. But when blood encounters a chest tube, it doesn't see it as an aid to recovery, it sees it as a foreign object. Naturally, the body's clotting process is activated, causing the tubes to clog with blood clots and debris. This can be life threatening to patients. Nurses often have to improvise to keep the tubes open by tapping, squeezing, and milking the tubes in an attempt to clear the clots. This can be frustrating and time consuming. And, since the thick, "garden hose" like tubes are often threaded through the patient's ribs, these methods can cause a lot of pain. What's worse is that clogged tubes hurt patient outcomes, particularly when clots form in the part of the tube that's inside the patient and out of view. Such clots can mask dangerous blood loss and infection, putting the patient at risk for potentially fatal complications.

Improvised attempt to clear standard chest tubes

The surgeons who helped found Clear Catheter knew there had to be a better way. They envisioned a system that would allow for clots to be cleared without breaking the sterile field. They enlisted Carbon Design Group to help them create a solution that would improve patient outcomes, give nurses a much-needed tool, and reduce patient pain in the process.

Carbon engineers and industrial designers worked in concert on the development of the device, incorporating valuable insights provided by Clear Catheter surgeons. Clear Catheter engaged Xeridiem (then known as MRI Medical) for manufacturing design & development, regulatory submission support, supply chain management and order fulfillment. Xeridiem and Carbon collaborated as the PleuraFlow Active Tube Clearance System was optimized for manufacturablity.

The final result is the PleuraFlow Active Tube Clearance System. As the first chest tube with a mechanism for actively clearing blood clots, the PleuraFlow Active Tube Clearance System represents the most significant innovation in chest tubes in half a century. "Installing a PleuraFlow chest tube system is very close to the current procedure," said Paul Leonard, head of Carbon's medical programs. The difference with the PleuraFlow Active Tube Clearance System is that the system incorporates a metal loop at the end of a guide wire inside the tube. A guide sleeve outside the tube is connected via magnetic coupling to the guide wire. This allows the nurse to manipulate the wire by shuttling the guide sleeve back and forth along the along the tube without breaking the sterile field. "It's probably one of the most innovative parts of this device," said Dr. Ed Boyle, cardiothoracic surgeon, founder and company CEO. "This configuration allows nurses to quickly clear chest tube blockages- even the unseen blockages inside the chest cavity."

Independent investigators in a recent Cleveland Clinic study published by the Annals of Thoracic Surgery compared drainage from a large diameter (32 french) standard chest tube and that from a smaller (20 french) PleuraFlow Active Tube Clearance (ATC) chest tube. The study concluded: This is the first time a smaller diameter chest tube has been shown, with the ATC, to drain better than a larger diameter chest tube. Though the PleuraFlow Active Tube Clearance System is available in both the large and small diameters, the results of this study indicate that doctors may be able use the smaller PleuraFlow Active Tube Clearance System to reduce patient pain, while still delivering better drainage than the larger, standard chest tube.

The device received FDA approval in December 2010 and had previously received approval for both the Canadian and European markets. In addition to the MDEA win, the proprietary device received the 2009 European Association of Cardiothoracic Surgeons Techno-College Innovation Award in the worldwide competition to identify innovations with the potential to change the standard of care in heart and lung surgery. The PleuraFlow Active Tube Clearance System has also been recognized as a Design Distinction winner for the I.D. 2010 Annual Design Review.

"We couldn't be more delighted with the MDEA recognition," said Dan Blase, President of Carbon Design Group. "We're even more excited at the potential for the PleuraFlow Active Tube Clearance System to help doctors and nurses improve patient outcomes and reduce healthcare costs."

"It's rare to have such a big unmet clinical need, solved with such an effective, functional device," commented Karl Sprague, Project Leader, Xeridiem Medical Devices. "This device provides clinicians with a great solution for post-operative patient care. Best of all, this will help reduce patients' follow-up surgery because clinicians now have specific treatment tools. We're helping people get better faster."

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