PleuraFlow for Clearing Chest Tubes Wins Prestigious Design Award
From medGadget: “PleuraFlow, a device we reported receiving FDA approval last December, won a 2011 Medical Design Excellence Award. The device from Bend, Oregon’s Clear Catheter Systems clears chest tubes of clogging material using a magnetic guidewire. Of note, the technology was designed with help from Carbon Design Group of Seattle, Washington.”
The Medical Design Excellence Awards (MDEA) competition is the premier awards program for the medical technology community, recognizing the achievements of medical product manufacturers and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for the groundbreaking innovations that are changing the face of healthcare. Entries are evaluated on the basis of design and engineering features that improve healthcare delivery, change traditional medical attitudes or practices, and provide enhanced benefits to the patient.
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.
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 full-service product development consultancy 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,” says 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,” says 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.”
“We couldn’t be more delighted with the MDEA recognition,” says 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.”
Presentation of the 2011 Medical Design Excellence Awards will take place on Wednesday, June 8th in a ceremony at the Medical Design & Manufacturing (MD&M) East Conference and Exposition in New York City.
Read the medGadget post.
Download the full Press Release.
High resolution images available for download here.
Embeddable animation available on YouTube.
See PleuraFlow in Projects.