Carbon Design Group

Clear Catheter Systems PleuraFlow System

The first major chest tube innovation in half a century. As the first chest tube with a mechanism for actively clearing blood clots, the PleuraFlow™ Active Tube Clearance™ System successfully addresses a problem that had defied solution for decades. PleuraFlow improves patient comfort and outcomes, saves time for medical staff, and lowers medical costs.

Hidden Dangers

A vital component of post-surgical recovery.

After major heart or lung surgery, chest tubes are installed to drain air and fluid from the surgical site and aid in recovery. As the body heals, maintenance is required to keep the tubes clear and avoid blockage caused by the natural clotting process.

Mechanical Advantage

Nurses often have to improvise to keep the thick tubes open by tapping and squeezing. This can be frustrating and time consuming for nurses and painful for patients. What’s worse, clogged tubes hurt patient outcomes. They can mask dangerous blood loss and infection, putting the patient at risk for potentially fatal complications.

Standard chest tubes are difficult to keep clear of clots, especially within the body.

Clear Catheter Systems envisioned a system that would allow for clots to be cleared without breaking the sterile field. Carbon engineers and industrial designers worked in concert on the development of the device, incorporating valuable insights provided by Clear Catheter surgeons.

The final result is the PleuraFlow Active Tube Clearance System. To keep the chest tube clear, the device incorporates a metal loop at the end of a guide wire inside the tube. The open loop allows fluids to flow freely, yet is extremely effective at removing clots.

PleuraFlow employs a wire loop to clear the inside of the tube mechanically.

Magnetic-Drive Preserves Sterile Field

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. This configuration allows nurses to quickly clear chest tube blockages—even unseen blockages inside the chest cavity.

Squeezing the thumb pads releases the shuttle body, freeing it to slide over the tube. As the shuttle is pulled back, the guide wire retracts and the clot is cleared.

Magnetic coupling occurs through the tube’s sterile barrier, allowing a user outside the sterile field to manipulate a magnet within.

Results that Matter

A recent Cleveland Clinic study 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 that, “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 PleuraFlow is available in both the large and small diameters, the results of this study indicate that doctors may be able use the smaller PleuraFlow to reduce patient pain, while still delivering better drainage than the larger, standard chest tube.

The proprietary device received FDA approval in December 2010 and has previously received approval for both the Canadian and European markets. It received the 2009 EACTS Techno-College Innovation Award given by the European Association of Cardio-Thoracic Surgeory. The worldwide competition recognizes innovations with the potential to change the standard of care in heart and lung surgery. PleuraFlow has also earned a Design Distinction award for the I.D. 2010 Annual Design Review. In 2011, PleuraFlow was awarded Gold in the prestigious Medical Design Excellence Award competition. “It’s a simple idea that solves a complex problem,” said MDEA juror John Sinacori, an assistant professor in the department of otolaryngology at Eastern Virginia Medical School.

By speeding recovery times and reducing expensive complications, the use of PleuraFlow significantly reduces the cost of recovery from heart and lung surgeries.

Contributions
  • Industrial Design
  • Mechanical Engineering
  • Quality Engineering
  • Research
  • User Interaction
Award(s)

2011 MDEA Gold

2011 Good Design Award

2011 Spark:Pro Bronze Award

2010 ID Award

2009 EACTS Award

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