PleuraFlow® has been recognized with a 2011 GOOD DESIGN™ award in the Medical category. Founded in 1950, The GOOD DESIGN™ award is one of the world’s most prestigious international awards program for new industrial design.  PleuraFlow® was selected from over 500 product designs from over 38 nations. This award comes to the company via its collaboration with Carbon Design, which helped design the PleuraFlow® Active Tube Clearance® System.

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http://www.dexigner.com/news/24548

http://chi-athenaeum.org/gdesign/2011/medical/348.html

BEND, Ore., — Clear Catheter Systems, Inc., a leading developer of medical devices used in post surgical recovery announced that it has closed its first institutional round of financing. The $4 million round was co-led by Aphelion Capital and California Technology Ventures. Also participating in the financing was Research Corporation Technologies. Ned Scheetz, of Aphelion Capital and Alex Suh, of California Technology Ventures will join the board of directors. Clear Catheter Systems will utilize the capital from the latest round to respond to increasing demand for its lead product, the PleuraFlow® Active Tube Clearance® System, and drive commercialization in the United States and abroad.

“This investment is a great vote of confidence in Clear Catheter’s mission to deliver technology that will improve post surgical outcomes and reduce healthcare costs,” said Clear Catheter’s CEO, Ed Boyle. “These investors have significant experience working with high-growth medical device companies like ours, and we’re thrilled to have Ned and Alex joining the team.”

“Clear Catheter’s Active Tube Clearance® System is a groundbreaking technology to aid in the post operative recovery from surgery,” said Ned Scheetz. “We believe Clear Catheter’s PlueraFlow® system can improve hospital profitability by reducing the high costs associated with post surgical complications, and simultaneously improve patient care.”

PleuraFlow® has been recognized with a 2011 Spark Award.

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The winners of the 2011 Spark:Pro Awards were selected this week by a jury of experts from design media, and education. Encompassing a spectrum of categories including architecture, graphic design, branding, and product design, the Spark Awards recognize design’s ability to act as a catalyst, address problems, and improve lives.

Winning a Bronze award, the PleuraFlow® Active Tube Clearance® System is the first chest tube with a mechanism for actively clearing blood clots. After heart or lung surgery, chest tubes are installed to drain fluids and air. Unfortunately, these tubes routinely clog with blood clots and debris putting the patient at risk for potentially fatal complications. With PleuraFlow®, a guide sleeve outside the tube is connected via magnetic coupling to the internal guide wire. This allows the nurse to manipulate the wire by shuttling the guide sleeve back and forth along the tube. This configuration enables nurses to prevent blockages by quickly clearing debris build-up—even the unseen build-up inside the chest cavity—without breaking the sterile field. Designed and developed for Clear Catheter Systems and manufactured by Xeridiem, PleuraFlow® delivers better patient outcomes while reducing pain due to traditional, marginally-effective, clot-clearing methods.

Spark winners, media, and design fans will gather October 21st at the Autodesk Gallery in San Francisco for a celebration and exhibition. The Spark winners will also be showcased in Guangzhou Design Week, one of the largest, most influential and comprehensive international design festivals in China. Winning designs will also be featured in Spark’s first annual yearbook being created by world-famous designer Kit Hinricks of Studio Hinrichs.

Clear Catheter Systems, Inc. (Bend, Oregon) is pleased to announce that they have hired a new Vice President of Sales and Marketing Worldwide, Sri Rao. Mr. Rao has 18 years of sales and management experience in the medical device field.  His focus has been almost entirely cardiac surgery, and for the last 12 years has been with start-up medical device companies specializing in introducing new products to the market.  Most recently he was in Sales Management at Estech, a cardiac surgery focused company where he managed a sales force with a focus on RF ablation, valve replacement and repair, and coronary artery bypass grafting.  Prior, Mr. Rao held Sales and Sales Management positions at ATS Medical (Acquired by Medtronic), Cryogen Inc. (Acquired by American Medical), VIA Medical, and US Surgical (now Covidien).  Mr. Rao has a Bachelor of Science degree from Purdue University, School of Engineering and Technology.

“Sri  is a consummate sales management professional, and his successful track record in building high performing sales organizations will help Clear Catheter Systems accelerate the expansion of our commercialization efforts,” said Edward Boyle, Chief Executive Officer of Clear Catheter Systems. “Particularly noteworthy is Sri’s depth of experience in introducing new medical devices over the course of his career, which makes him an ideal candidate for our organization. I am very pleased to have him join our senior management team.”

By: Shana Leonard

Cardiothoracic surgeon Edward Boyle was a man on a mission when he partnered with Cleveland Clinic heart surgeon Marc Gillinov to establish Clear Catheter Systems Inc. (Bend, OR). After years of observing clogs and blood clots form in chest tubes and their resulting adverse effects on patients, Boyle was determined to develop a solution that overcame this dangerous design flaw. Responding to this unmet clinical need, Clear Catheter has introduced the PleuraFlow® Active Tube Clearance® System to prevent chest tube occlusion and improve patient safety.

Following heart, lung, or trauma surgery, chest tubes are inserted into patients and coupled to a drainage system in order to remove excess fluid or air from the body. “A lot of what is drained is blood,” Boyle, CEO of Clear Catheter, explains. “If blood clots or coagulates in those tubes, which it tends to do, then they don’t drain very well. If that happens, it can contribute to complications and impair outcomes.” Complications resulting from clogged chest tubes can include a pneumothorax, pericardial tamponade, and excessive blood loss—the latter of which can occur if blood pools unnoticed in the chest cavity as a result of a clot formation in the portion of the tube positioned inside the body. Difficulty even arises when a clot is quickly identified in the chest tube, Boyle adds, because current methods of removal are undesirable for clinicians and may cause additional discomfort or risk for patients.

In an effort to avoid these unnecessary complications, Clear Catheter developed the PleuraFlow® system. The product consists of a standard chest tube that is inserted into the patient and then connected to a guide tube, over which is a shuttle guide set. The guide tube is then connected to a standard chest drainage system. Located within the guide tube, a guidewire featuring a distal loop moves backward and forward in the chest tube via a proprietary drive system to prevent clot formation. “We call this Active Tube Clearance®,” Boyle comments. “No other products have anything on the inside; they’re just a tube. With the PleuraFlow® system, we’re moving from passive drainage to active drainage.”

To develop the PleuraFlow® system, Clear Catheter Systems, armed with the initial concept for the clog-preventing device, sought the expertise of product development consultancy firm Carbon Design Group (Seattle) to help take the idea to the next level. Together, engineers and designers from both companies participated in brainstorm sessions to determine the optimal design of the system. “One of the most important design elements was that we had to figure out how to move the guidewire inside the tube from outside the tube,” Boyle recalls. “You can’t have an opening or a hole in the tube because that breaks the sterile barrier on the inside.”

A design epiphany came in the form of magnets, notes Robert Hubler, an industrial designer at Carbon. “There’s a magnet on the inside of the plastic tube that’s attached to the guidewire; on the outside, you have another magnet,” he explains. “The magnets will attract each other through the tube because the tube is naturally very slick on the inside and the magnet is a polished metal piece. So, it’s easy for the magnet to move on the inside of the tube with that attraction to the other magnet that’s moving back and forth without breaking the sterile barrier.” This back-and-forth movement of the guidewire in the tube serves to break up blockages, thus encouraging fluid flow and preventing coagulation.

Once the use of magnets was agreed upon, Carbon launched into the industrial design, mechanical engineering, and testing of the PleuraFlow® system based on feedback from Boyle and his surgeon colleagues. “Once Clear Catheter decided it wanted to go with the magnetic solution, we figured out a scheme for the use of the device pretty quickly,” Hubler says. “The basic architecture is that the shuttle gets released, moves back and forth, and then docks back in the home position.”

As part of the design and development process, Carbon took a close look at the forces required for the system. One challenge it faced was striking a balance so that the magnets provided enough force to drive the guidewire without interfering with nearby telemetry and other electronic systems. Achieving a balance in decoupling force also proved to be challenging. It needed to be strong enough to withstand the force of clot removal but forgiving enough to allow for separation of the wire in the shaft, if necessary, for safety reasons.

Upon finalizing the design and engineering with Carbon, Clear Catheter approached Xeridiem Medical Devices (Tucson, AZ), a company specializing in the design, development, and manufacture of complex, single-use medical devices. “We optimized the design for manufacturability,” says Mike Cusack, director of business development at Xeridiem. “We developed a manufacturing process and ensured that the device would work within the requirements of the ICU.”

Xeridiem also molded the silicone housings, and assembled, tested, packaged, and sterilized the device. The company helped with regulatory filings for the PleuraFlow® system as well. In essence, Cusack remarks, Xeridiem has served as the bricks and mortar of Clear Catheter Systems in that it manufactures the PleuraFlow® in addition to taking orders, providing technical support, answering phones, maintaining inventory, shipping for distribution, and invoicing.

Obtaining FDA approval in December, the PleuraFlow® system offers a simple solution to the common—and life-threatening—problem of chest tube clogging. And if that weren’t enough, it offers the additional benefit of enabling the use of smaller chest tubes. “Rather than using large chest tubes that look like a garden hose, our goal is to eventually be able to use a tube that is smaller and maybe only the size of a drinking straw,” Boyle says. “We think that it will not only help reduce complications, but it will also improve patient comfort.”