Sleep Diagnosis and Therapy Vol 5 No 7 November-December 2010
Flashy CPAP units and masks dominate the sleep technology landscape, but the right tubes can mean the difference between compliance and failure.
Manufacturers are always looking to build a better mousetrap, but what if the trap already works? The solution may lie in improving the parts while leaving the fundamental design essentially unchanged. Plastiflex engineers and market experts examined the sleep technology market and determined that their expertise in industrial tubing systems could bolster the all-too-common weaknesses found in CPAP systems
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A New Solution for CPAP Tubing
After an exhaustive fact-finding period that took company officials to numerous trade shows and visits with industry leaders, designers narrowed down CPAP tubing complaints to condensation and comfort. According to Rik Langerock, marketing manager for Plastiflex Healthcare, condensation in the breathing circuits was a persistent problem, and a key area where his Belgium-based company could make a difference.
“We spoke to many different people in the supply and value chain and it was condensation in the respiratory tubes that we found to be significant,” says Langerock. “A second related need was about bringing more comfortable air to the patient.”
Comfort usually means warmer and/or more humid air, and this is where Plastiflex is able to use its considerable expertise. Other factors such as mask materials and proper fit play a role, but Langerock and his team were determined to only tackle what they knew best. “You must understand what matches with your core competency as a company,” says Langerock. “Our core competence is in the design and manufacturing of hose systems solutions.”
Hybernite® Rainout Control (ROC) System
Plastiflex engineers ultimately came up with the Hybernite® Rainout Control (ROC) System, which includes the proprietary Hybernite® Heated Breathing Tube (HBT) and Hybernite® Power Supply Unit (PSU). The HBT connects to the PSU via a plug and-play connector, with copper wires embedded in the tubing wall. These wires generate heat that maintains air temperature inside the tube, ultimately warding off problematic condensation. The wires are positioned for uniform heating along the tube’s entire length, a system that avoids water droplets on the wall of the tube and the resulting accumulation of moisture.
Targeting America and Europe is no small endeavor, but Langerock says the relative simplicity of the message will likely resonate on both continents. The Hybernite® ROC consists essentially of two main parts; one is a heated breathing tube and the other is a power supply. With standard conical connectors, Langerock is confident that the Hybernite® ROC can fit the role of a universal solution that can be fully integrated into any humidifier— including all types of masks that use standard tubes. “We have been working on this for a long time obtaining all the regulatory approvals,” says Langerock. “Plastiflex Healthcare is ISO 13485 and QSR certified, as are our manufacturing locations. This makes us a Tubing System Original Equipment Manufacturer (OEM) with the ability to sell tubing systems under our own brand like Hybernite or work closely with other manufacturers for customized products.”
Langerock reiterates that the Hybernite® ROC is a universal heated breathing tube system. “It is also stand alone,” adds Langerock. “The system itself does not take power or require power to be taken from the humidifier. It takes the energy straight out of the socket in the wall via the PSU. A second important feature is that the system is independent. It is not specific to one type of device. It works with all humidifiers that currently use standard tubing. As long as you are using standard tubing, which is 99% of the market, all those devices can also work with the Hybernite.”
Tubes are not often the focus of large marketing pushes, but extolling the virtues of proper accessories is a message that Plastiflex officials hope will find a home. At its core, Langerock believes that increasingly sophisticated clinicians, and even patients, will demand the best products for their therapy. “These tubes will improve the comfort of the patient,” says Langerock. “You will have no more condensation in the tube, no more gurgling noises, and far less pressure fluctuations.”
Avoiding condensation means users can optimize the humidity output of humidifiers for better personal comfort and improved clinical efficacy. “The result of not having condensation is being able to turn up your humidifier instead of turning it down,” explains Langerock. “Another factor for the patient is the convenience and ease of use. The industry also knows that there are factors that will contribute to better compliance, and humidification is an important contributor.”
For sleep labs, the convenience of so-called plug and play fosters a universal solution for the heated breathing tube. Sleep centers may even be interested in conducting their titrations in combination with heated humidification and a heated tube. “There is literature that says that heated humidification in combination with heated tubing lowers titration pressure *,” adds Langerock. “So, from that perspective, our tubes give sleep technicians an opportunity to do more titrations with humidification.”
*Massengill, J. and Lewis K.L.Effect of humidification and titration pressures on obstructive sleep apnea. Sleep. Volume 32, Abstract Supplement, 2009 A217
Plastiflex Healthcare is a division of Plastiflex Group NV. Plastiflex Group is the world leader in the development and manufacturing of flexible hose system solutions for floor care, pool, white goods and industrial applications. Plastiflex Group has 9 manufacturing locations – 3 in Europe – 3 in Asia/Pacific – 3 in North America. Plastiflex Healthcare is a new venture within Plastiflex and focuses on identifying, developing and marketing new products and technologies in the area of respiratory care, particularly sleep disorders, Non Intrusive Ventilation (NIV) and critical care ventilation. Plastiflex Healthcare is QSR compliant, ISO 13485 and Annex II – Directive 93/42/EEC (design controls) certified.