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With the aging population—and individuals aged 60+ expected to increase from 962 million in 2017 to over two billion globally in 2050—and increasing demand for quality health care, the manufacture and use of many medical products and devices are on the rise. These trends are fueling demand for more advanced, smaller, lighter-weight medical equipment that require advanced parts that are reliable, proven and can withstand rigors of use to enhance quality of life.
One example of increasing demand for smaller, lighter, more durable medical equipment is portable oxygen concentrators (POCs). These compact, lightweight systems can provide a more suitable alternative to stationary oxygen concentrators as some POCs weigh less than two pounds versus 40 or more for stationary equipment. They are becoming one of the fastest growing segments in the home oxygen supply market for their ability to deliver oxygen therapy to patients, even “literally” on the move. Approved for air travel by the FAA (Federal Aviation Administration), POCs can improve quality of life for patients with chronic or acute respiratory diseases like pulmonary hypertension and fibrosis. They can also provide much-needed relief to children with congenital heart diseases, cystic fibrosis or severe cases of asthma.
The Concentration on Helping People to Breathe & Move Easier
The market for all medical oxygen concentrators is expected to rise to $2 billion by 2023 according to Global Markets Insights. The Global Portable Oxygen Concentrator market will comprise much of the market, growing at a 1.56% CAGR from $996 million in 2017 to $1,721 million (in U.S. dollars) by 2022 says Research and Markets.
North America will continue to have the highest market share through 2022, given the increase in COPD, aging populations and a large number of manufacturers driving use. However, Research and Markets projects that POCs will also experience significant growth in Europe between 2017 and 2022 given higher incidences of smoking and respiratory disease. In Asia Pacific, this area is expected to grow, with preferences for home medical treatments, increased aging (with the “graying of China” and about 22% of the population expected to be over age 60 by 2027 and one study suggesting 100 million adults may have COPD in China), and increased pollution from industrialization.
The Critical Role of Seals & Polymer Parts in Oxygen Concentrator Systems
Oxygen concentrators (also known as oxygen generators) come in stationary (home) and portable units (mobile) that is unique from other oxygen delivering systems because of the compressing element. They typically use an air compressor along with other parts such as a cylinder, flow meter, valve and tubes to compress oxygen from ambient air, remove the nitrogen and deliver purified air to the patient. The compressor in a POC compresses the ambient air, to be filtered into the concentrator; this is then fed into one of two sieve bed filters that take turns removing nitrogen from the air. The patient is fed pure oxygen from the POC as the final result. A stationary unit is beneficial for patients who are not as mobile and for home use, providing a more stable source of oxygen during sleep.
Seals in the compressors play a critical role in ensuring functionality of the oxygen system. They need to operate in two different ways: (1) as a bearing to enhance movement of the piston up and down the cylinder wall, and (2) as a seal to prevent air from seeping from the chamber while it is being compressed by piston movement. Cup seals, which function similar to a lip seal, can handle very high pressures and are often used in this application.
Saint-Gobain Seals’ Rulon® polymer cup seals are particularly useful in this life sciences application. In China, the seals are used more in stationary units due to cost, need, medical coverage and government regulations. However, home oxygen therapy is growing rapidly with the increase in asthma due to air pollution; it is expected to become a $2.5 billion market in 2023 with Chinese vendors pushing to enter worldwide markets. In other areas such as North America, the cup seals are more often found in POC systems since patients usually prefer a portable medical device that offers convenience and supports a more active quality of life.
Rulon® PTFE material is a precise fit for the concentrator application as it is a versatile, high-performance family of proprietary, homogenous filled materials that offers high wear life, low friction, and withstands harsh conditions, including dry running, exposure to aggressive chemicals, and abrasion. It can also operate in extreme temperature and pressure ranges. There are many grades of Rulon® material that can be custom designed into bearings, piston rings, cup seals and other critical parts.
Because of its extremely low friction, low heat, low noise, long wear life and low maintenance, the Rulon® product has been successfully used in piston cup seals for years in both stationary and portable oxygen concentrators. Rulon® J material (which offers one of the lowest levels of coefficient friction in reinforced PTFE materials and is frequently used in automotive start and stop applications), Rulon® 1189 and Rulon® 1694 grades are frequently used in POCs.
Specific benefits of Rulon® cup seals in this application include:
- Increased durability and reliability due to the material’s long life with an estimated wear life of 20,000 hours and low friction/heat with the ability to work in temperatures from -40ºF to 212ºF (-40ºC to 100ºC)
- A strong seal with the ability to withstand pressures of 29 psi/two bar and speeds of 0.5 meters per second
- Decreased total costs resulting from post-sale cost savings on training, technical support, installation, maintenance
- Versatile customized designs with the potential for manufacturers to design even smaller and lighter concentrators with Saint-Gobain Seals’ ability to formulate materials to address specific needs, designs, and exact shapes
- Dry running with seals in oxygen concentrator systems needing to run dry with less oil and be chemically inert
With over 100 standard Fluoroloy® and Rulon® grades available, many of which are FDA compliant and USP Class VI certified, these materials are not only well suited for medical devices but also analytical equipment. Saint-Gobain Seals’ Rulon® compounds and OmniSeal® spring-energized seals have also been used in orthopedic and laparoscopic power tools, harmonic scalpels, chemical analyzers as well as other critical life sciences applications, such as the following:
Ultra-High Performance Liquid Chromatography (UHPLC) & High Performance Liquid Chromatography (HPLC) systems: Where parts are regularly exposed to chemicals in separating, identifying and quantifying compounds, Rulon® polymer bearings help to maximize equipment run time and OmniSeal® Fluoroloy® G piston pump seals ensure high seal pressure (with ratings of up to 18,000 psi/1,240 bar), wear resistance, quality and consistency.
In-vitro diagnostic medical devices (IVDs): Saint-Gobain Seals’ design team in Japan worked closely with manufacturers to ensure reliability of this equipment that tests blood and other samples to monitor health and assess medical conditions for patient care. Today’s IVD systems need to run faster and longer than before, and low friction materials address these requirements.
Surgical tools – OmniSeal® and Rulon® parts are used in components in these precise fit solutions, enabling smaller, more accurate surgeries. The parts offer low friction and longer life in motor, actuator and linear guide applications.
Portable insulin delivery – Rulon® and Meldin® materials are used in parts to effectively seal these wearable pumps from moisture to consistently deliver precise doses of insulin. The components can also run dry, are chemically inert and support low friction and long life, necessary for these units.
With over 22 FDA Compliant or USP Class VI materials, Rulon® and other materials from Saint-Gobain Seals are often used in bearings in pharmaceutical and food industries for their ability to support strict sanitation requirements. Rulon® 641, as just one example, is the only filled PTFE material that is FDA compliant with USP Class VI approval for direct contact with human tissue and fluids.
Along with the power of their polymer lines, Saint-Gobain Seals has been supporting life sciences partners for over 30 years with strong design engineering expertise and research and development capabilities. Within applications that directly impact patients and the way they live daily such as oxygen concentrator systems, Saint-Gobain Seals is focused on giving customers and their end users the “breathing room” they deserve.
Contact us today to learn more about how Rulon® material and other sealing solutions can support your life sciences application in cost-savings and reliable lifetime performance.