Solvay's Zeniva PEEK Biomaterial Finds Application in Envoy's Implantable Hearing System

Envoy Medical Corp., St. Paul, Minn., has developed the industry's first totally implantable hearing system for moderate to severe sensorineural hearing loss. The Esteem® prosthetic hearing restoration device features two terminal connectors made of Zenivapolyetheretherketone (PEEK) resin from Solvay® Specialty Polymers USA, LLC. Zeniva® PEEK - part of Solvay's family of Solviva® Biomaterials - provides biocompatibility, strong insulative properties, and excellent mechanical performance. 

Unlike hearing aids, the Esteem implantable hearing device does not use a microphone or a speaker. Instead, it uses the natural ear drum to detect sound and send a clear message to the brain, via the auditory nerve, by stimulating the cochlea with its prosthetic simulator. Last year, Envoy Medical received pre-market approval (PMA) from the U.S. Food & Drug Administration (FDA) for commercial distribution of the Esteem® implantable hearing device.

"We believe that the Esteem implantable hearing system represents a major breakthrough that provides an alternative to non-implantable and partially implantable hearing aids," said Kevin Verzal, research and development engineer for Envoy Medical. "Zeniva PEEK provides the exceptional properties that are required of a high-precision implant in this critical application."

The innovative design incorporates two terminal connectors (0.1-in by 0.5-in / 2.5 mm by 12.7 mm) for the transducers which are injection molded of Zeniva® PEEK. The biomaterial offers better insulative properties and higher mechanical strength than previously used materials like silicone. Zeniva® PEEK offers many important benefits including biocompatibility and chemical inertness. Based on biocompatibility testing, Zeniva® PEEK demonstrates no evidence of cytotoxicity, sensitization, irritation, or acute systemic toxicity. It also boasts high strength and stiffness and has radiolucent properties which permit x-ray procedures.

Zeniva® PEEK and the entire line of Solviva® Biomaterials are manufactured in compliance with the relevant aspects of ISO 13485 and under the relevant aspects of current Good Manufacturing Practices. Solvay's biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an accredited lab that is ISO 17025 compliant.

Envoy® Medical sells the Esteem implantable hearing device directly to patients. The company matches patients with Envoy-approved surgical centers throughout the U.S. along with its own independently owned surgical center in The Woodlands, Texas.

In addition to Zeniva® PEEK, Solvay's line of Solviva® Biomaterials includes Proniva® self-reinforced polyphenylene (SRP), one of the world's stiffest and strongest unreinforced thermoplastics that offers exceptional biocompatibility and hardness; Veriva® polyphenylsulfone (PPSU), which provides unsurpassed toughness combined with transparency and excellent biocompatibility; and Eviva® polysulfone (PSU), which offers practical toughness in a strong, transparent polymer. These sterilizable products are available in resin for injection molding or extrusion.

Petcore Introduces Innovative Recycling Method to Manufacture Plastic Pellets Using Ocean Litter

Production-run pellets made partially from plastic ocean litter have become a reality, thanks to 18 months of cooperation between packaging brand designer Method and recycler Envision Plastics Industries LLC.

The first batch of pellets streamed off the production line at Envision's Chino plant around noon March 1. Executives from both companies beamed with pride and excitement, and captured the technology breakthrough, snapping pictures and video. They then watched as the otherwise unassuming black pellets were loaded into 1,200-pound boxes, ready to be molded into a Method-designed container that will hit a major grocery chain this fall. "We did a couple of fist pumps," smiled Adam Lowry, co-founder, CEO and chief groundskeeper of the SanFrancisco-based Method, whose packages are made from 100 percent recycled materials.

Lowry declined to name the product that will be made from the ocean scrap, but he said that it will be an existing product, in one of the company's "iconic shapes." Method-brand products include household and personal-care items. The container will be made by a major plastics packaging blow molder. The two companies overcame obstacles to reach this point.

A major one: Plastic made from ocean litter is more brittle than traditional recycled plastic because of exposure to ultraviolet light and ocean degradation. The two companies had to develop the right blend of materials for the pellets, which initially will be made from 75 percent traditionally recycled high density polyethylene and 25 percent ocean litter. The litter is a 50-50 mix of HDPE and polypropylene that was collected on Hahuku Beach on the island of Kaui in Hawaii, where it had settled after floating down from the North Pacific Gyre.

"It's something we've worked together on for longer than a year," said Parham Yedidsion, a co-owner of Envision Plastics. "The ocean scrap is ??more challenging, so we had to do a lot of testing and qualification work." In addition, he said ocean scrap requires more hand-sorting because of the need to take out items such as buoys and plastic nets. The material also runs through optical sorters before it is ground into flake, washed, and blended with traditional post-consumer HDPE flake, before being fed into an extruder and repelletized.

Method employees - in cooperation with school groups and beach-cleaning groups - collected the material for the initial production run from three very large beach cleanups in slightly more than one year.

Method does not know the exact amount of material it has recycled from Hahuku Beach. But in one sweep, "We collected 3,700 pounds of plastics in two hours," said Rudi Becker, packaging director and chief resonator, who helped collect the plastic litter with a couple of dozen school-age children on that trip. "It's an eye-opening, surreal experience to go there and see it," Becker said. "Sometimes, it's overwhelming because the beach is no cleaner when you are done than when you started because more plastics scrap washes up before you're done." Neither Becker, Lowry or any of the Envision executives have any delusions that their work can clean up the Pacific Gyre. But the companies want to raise awareness of the need to reuse plastic over and over and over again.

"There is a tremendous amount of little fragments of plastics on the top layer of the ocean in the gyre and it is an amount of litter that is literally impossible to clean up," Lowry said. "As long as we continue to make new virgin plastics instead of recycling plastics products, this problem gets worse. The real solution to the plastics pollution problem is to use the plastics we already have on the planet. If you don't make new plastics, you don't create new waste," he said.

Yedidsion agreed. "We need to educate people to recycle plastic packaging and products as opposed to throwing them away." He said Envision got involved in the project because it sends the right message. "We always look at how we bring high value to our customers and to ourselves," he said. "Every step of the way - like with these first boxes of pellets today - we try to push the company forward and raise that bar."

Lowry said the pellets are the first phase of the 12-year-old company's plan to raise awareness of the plastics pollution problem. "Phase one of this project is to just go out and get the plastics we need to make this product," he said. "We know we can go and collect it and all it takes in man-hours. In phase two, we want to work with a lot of beach cleanup organizations all over the world and we want to set up a network to intercept that plastic scrap before it goes to landfills. We can scale it much larger and that is the way to do it.

"The world is going to need a lot more products that are designed more sustainable," Lowry said. "We are going to have to dig deeper and make science-based decisions about those things and what is best from an environmental standpoint. We want to do something innovative that makes a change in the market and have an impact larger than our [physical] size and presence in the market."

Define Kindness

Kindness is the basis of happiness. Kindness is the basis of the life we live. Kindness is the basis of the dharma. The basis of practicing the dharma should be on a caring positive mind. So kindness is understanding. Kindness is a thing that you don't take advantage of. It is seeing that it is directly and indirectly benefiting you. For example, if you are giving alms to a beggar and if you have a feeling of savior or superiority, then think twice. Who is doing a favor to whom. I would say that the beggar is doing a favor to you. If there is no beggar, and if you have the motivation of accumulating merit by giving alms to beggars, then who are you going to give to? Kindness can produce a good caring heart. So think of kindness towards your parents who care for you, your friends who are doing something special to you, and even to a waiter who is serving you. Don't take advantage of that or think you own that because it is their responsibility or that they should since you are paying for it. 

Kindness can help you gain caring and showing kindness means you understand. So please practice kindness. When you think of kindness towards your teacher, you gain devotion. When you think of kindness towards your parents, you gain respect and caring. And when you practice kindness towards the general public, you become more positive and good hearted, naturally. When you practice kindness towards your loved ones, your understanding grows and so does your patience. So basically only by practicing kindness, you are producing more positive thoughts and as a result, improving the qualities of your life. 

For those of you who don't feel much kindness towards others, you should at least be very kind to your ego!  The most important key is that you need to see your own faults and to do this, you need to be kind to your ego. Because when you do so, you'll see your mistakes and the causes of those mistakes. 

Victrex Assures Supply of VICTREX PEEK® to Airplane Manufacturers to Uplift Aircraft Production Levels

Victrex Polymer Solutions, one of the leaders in high performance polyaryletherketones, has reaffirmed its security of supply in anticipation of increased demand as commercial airplane manufacturers plan to boost production rates to record levels.

Victrex issued a Security of Supply statement outlining its ability to provide VICTREX PEEK polymer at a time when many other polymer manufacturers are struggling to keep up with customer demand. Victrex has a proven track-record of investing in capacity ahead of demand, creating a stable supply position for its global customers across a wide and growing range of applications in the aerospace, automotive, industrial, oil and gas, alternative energy and electronics sectors.

Amphenol PCD, a subsidiary of Amphenol Corporation, one of the world's largest manufacturers of interconnect products, is a direct supplier on the Boeing 787 Dreamliner and a long-time Victrex customer. Amphenol PCD produces high performance wiring, cable, and hydraulic tubing clamps based on VICTREX PEEK that replace traditional metal P-clamps and Saddle clamps. Amphenol PCD chose VICTREX PEEK because of its superior strength and ability to reduce overall weight. As Amphenol attests, security of supply was also a very important consideration.

"In the aerospace industry, long-term stability and security of supply in our supply chain is vital," says Eric Rushbrook, General Manager, Amphenol PCD. "We therefore look very closely at all of our key suppliers' production capacity and quality control measures to ensure product availability and consistency and to enable us to meet our customers' demands both now and in the future. Victrex provided us the further assurance we need from one of our key suppliers due to its vertically integrated supply chain."

According to Tim Cooper, Managing Director at Victrex Polymer Solutions, "Offering a consistent, reliable supply of high quality VICTREX PEEK polymer ready for shipment to meet our existing and new customers' needs is an integral part of our strategy and focus. Our customers today, and in the future, can be confident in our ability to meet their needs for PEEK polymer on time and in full."

In order to improve fuel efficiency, airplane manufacturers are making extensive use of injection molded thermoplastics as well as composites, films, and pipes in next generation designs including a large number of lightweight structural components made with VICTREX PEEK polymer. In order to meet FAA safety requirements, qualified materials must often be certified to aircraft OEM specifications, their tier supplier specifications, and/or military standards (e.g. MIL-P-46183 for PEEK).

Because FAA certifications must be verified on every batch/lot, Victrex holds strategic stock of specified VICTREX PEEK grades based on forecasted demand. Additionally, the Company offers delivery for standard products with a maximum lead time of 5-7 days, and in many cases can deliver within three days.

ETH Zurich Researchers Create 2D Polymers that Form a "Molecular Carpet" on a Nanometre Scale

Scientists under the direction of ETH Zurich have created a minor sensation in synthetic chemistry. They succeeded for the first time in producing regularly ordered planar polymers that form a kind of "molecular carpet" on a nanometre scale.

At ETH Zurich in 1920, the Chemist Hermann Staudinger postulated the existence of macromolecules consisting of many identical modules strung together like a chain. For this he was initially rewarded with mockery and incomprehension in professional circles. But Staudinger was to be proved right: today the macromolecules described as polymers are known as plastics, and by 1950 one kilogram of them was already being produced per capita worldwide.

Today, more than ninety years after Staudinger's discovery - for which the chemist was honoured with the Nobel Prize in 1953 - about 150 million tons of plastics are manufactured every year. A gigantic industry developed, without whose products our daily life is no longer imaginable.

A research group led by Professor A. Dieter Schlüter and Senior Lecturer Junji Sakamoto at the Polymers Institute of ETH Zurich has now succeeded in making a decisive breakthrough in the synthetic chemistry of polymers: they have created two-dimensional polymers for the first time.

Intensive Discussions Led to Success

Polymers are formed when small single molecules known as monomers join together by chemical reactions like the links of a chain to form high molecular weight substances. Since qualifying as a lecturer, Schlüter was already occupied by the question of whether polymers can only polymerise linearly. Although graphene counts as a natural representative of a two-dimensional polymer - the carbon atoms in graphene form a honeycomb-like pattern through triple bonds - it cannot be synthesised in a controlled way.

Nevertheless, he said, if it is possible to produce giant molecules "one-dimensionally" from monomers, or for example molecules in pharmacology that are so small that they are practically "zero-dimensional", why then should it not be possible to develop a synthetic chemistry that generates two-dimensional molecules? When Schlüter and Sakamoto met at ETH Zurich a few years ago, they discussed this topic intensively and together they looked for answers.

The crux of the matter was to create oligofunctional monomers in such a way that they join together purely two-dimensionally instead of linearly or even three-dimensionally. Polymers of this kind must have three or more covalent bonds between the regularly repeating units. The scientists had to find out which bonding chemistry and environment was most suitable for producing this kind of "molecular carpet".

After intensive analyses of previous studies and the possible ways of generating two-dimensional polymers synthetically, they considered the synthesis at a water-air interface or in a single crystal, i.e. a crystal with a homogeneous layer lattice. The researchers decided in favour of the second alternative: the doctoral student Patrick Kissel successfully used this to crystallise special monomers which he had prepared into layered hexagonal single crystals. For this he generated photochemically sensitive molecules for which such an arrangement is energetically optimum. When irradiated with light with a wavelength of 470 nanometres, the monomers polymerised in all the layers.

Sheet-like Polymers with Regular Structures

After this the researchers boiled the crystal in a suitable solvent to separate the individual layers from one another. Each layer represents a two-dimensional polymer. The fact that the team really had succeeded in producing sheet-like polymers with regular structures was shown by special studies in an electron microscope carried out by Empa researcher Rolf Erni and Marta Rossell from ETH Zurich at the Empa (Swiss Federal Laboratories for Materials Science and Technology).

The polymerization method that was developed is so gentle that all the monomer's functional groups are also preserved at defined positions in the polymer. The researchers have complete structural control over the monomers in a way that would never be possible with graphene, for example, because that process would need to be carried out at enormously high temperatures. Sakamoto says, "Our synthetically manufactured polymers are not conductive like graphene, but on the other hand we would be able to use them for example to filter the tiniest molecules."

In fact there are small defined holes with a diameter in the sub-nanometre range in the regularly arranged polymers. Moreover, tiny hexagons in the polymers, formed by benzene rings with three ester groups, can be removed by a simple hydrolytic process. This would form a "sieve" with an ordered structure suitable for the selective filtration of molecules.

Unresearched Physics

However, before the researchers can think about practical applications, the task now is to characterise the material's properties. According to Schlüter, this is mainly a job for the physicists. One of the exciting questions in this respect will be how a two-dimensional polymer behaves compared to a linear polymer, for which a good physical and technological understanding is available. Schlüter assumes that two-dimensional polymers could have a different physics and will therefore also find different applications.

He mentions the property of "elasticity" as an example: intertwined linear polymers enable a stretched rubber band to snap back as soon as it is released. But because flat sheets can hardly entangle together, this would probably not work with planar polymers. However, the researchers must first of all find a way to produce larger amounts and even larger sheet sizes. The size of the crystals is currently only 50 micrometres. Sakamoto stresses that "those, however, are already enormous degrees of polymerization at a molecular level."

ClikTech Replaces Metal with Solvay's Radel® PPSU to Develop Novel Litening Rods™ for Medical Use

ClikTech Inc., Buffalo Grove, Ill., one of the leading manufacturers of dental sensor and x-ray film holders, has launched the industry's first thermoplastic rod for dental x-ray holder systems. The company's new Litening Rods™ , made of Radel® polyphenylsulfone (PPSU) resin from Solvay Specialty Polymers USA, LLC, replace metal rods which are labor intensive and more costly. The new product made of Radel® PPSU is light, autoclavable, reusable, and less costly. ClikTech will make the product introduction at the Chicago Dental Society's 2012 Mid-Winter Meeting Feb. 23-25 at McCormick Place in Chicago.

Metal rods have been used for decades in dental offices. Although effective, they are costly and prone to breakage, according to Thomas Gillen, president of ClikTech Inc. Metal rods require labor-intensive manufacturing steps including steel forming, bending, and pin insertion. "We have reached a time when we can combine both new and old technologies to produce the best available products at the most reasonable cost to the dental profession," explained Gillen. "These innovative rods serve as the bridge to make the transition from older to the newest technologies significantly easier for the dental office; they provide enhanced performance at a lower cost."

ClikTech developed Litening Rods™ in a close collaboration with XDR Radiology, Los Angeles, and its co-owner Dr. Adam Chen, DDS. Thermoplastic rods made of PPSU are stiff like metal but are 75% lighter, according to Gillen. The rods also offer easier handling due to an integrated handle grip design. They have the added benefit of incorporating a wire clip to accommodate the latest in digital sensors and work with any standard anterior, posterior, or bitewing ring. The rod attaches to a bite block receptacle which in turn holds the digital sensor.

Radel® PPSU is a super-tough thermoplastic with high heat resistance, exceptional hydrolytic stability and excellent chemical resistance. It can withstand over 1000 cycles of steam sterilization without significant loss of properties. It is inherently flame retardant and is resistant to bases and other chemicals. Radel® PPSU is also compliant with ISO 10993-1 for limited exposure, non-implantable applications. Litening Rods are 1/8-in square and five inches long and meet ISO 10993 and FDA requirements for intraoral use. They are commercially available through national dental distribution dealers.

Ajinomoto and Toray Sign Agreement to Conduct Joint Research on Biobased Nylon

Ajinomoto Co., Inc. ("Ajinomoto") and Toray Industries, Inc. ("Toray") have entered into an agreement to begin joint research for manufacturing the nylon raw material 1,5-pentanediamine (1,5-PD) from the amino acid lysine produced from plant materials by Ajinomoto using fermentation technology, and commercializing a biobased nylon made from this substance.

Biobased nylon is a type of nylon manufactured by polymerizing chemicals produced from plant materials. The biobased nylon that Ajinomoto and Toray will research and develop is produced from plant materials by decarbonating the amino acid lysine through an enzyme reaction to make 1,5-PD, which Toray then polymerizes with dicarboxylic acid. The amino acid lysine is a core product of the Ajinomoto Group produced using fermentation technology. This biobased nylon fiber made from 1,5-PD is not only sustainable because it is plant-based, but also shows promise for development into highly comfortable clothing. For example, nylon 56 fiber manufactured using 1,5-PD is pleasing to the touch, yet has the same strength and heat resistance as conventional nylon fiber made from the petrochemical derivative hexamethylenediamine. It also absorbs and desorbs moisture nearly as well as cotton.

The two companies have already carried out successful test production of 1,5-PD using Ajinomoto's feed-use lysine, as well as test production of biobased nylon made by polymerizing 1,5-PD. They plan to further expand the scope of their collaboration to include development of production processes and evaluation of use in textile and plastics applications.

This partnership between Ajinomoto, a leading manufacturer of amino acids, and Toray, a leading manufacturer of nylon, will enable the creation of biobased nylon products that are competitive in terms of quality, environmental protection and cost. Moreover, the companies will deepen their collaboration with a view toward using the membrane-integrated bioprocess being developed by Toray in the production technology for lysine, the raw material for 1,5-PD.

Through its businesses, Ajinomoto is working to contribute to solutions to the challenges facing humanity in the 21st century, namely global sustainability, food resources and human health. In its bioscience and fine chemicals business, Ajinomoto is leveraging core Bio-Fine (bioscience and fine chemicals) technologies to add biomaterials as a new business area in which it will work toward the realization of a low-carbon, sustainable, recycling-oriented society. To accelerate development of new businesses and products, Ajinomoto will continue to actively pursue open innovation through partnerships with other companies and organizations around the world.

Toray's management policy states that all business strategies must place priority on the global environment in an effort to help realize a sustainable low-carbon society. Under this policy, Toray is expanding its biomass-derived materials business centered on research and development of biomass-derived polymers, including biobased nylon and polylactic acid (PLA). Expanding the biobased polymer business is also an important initiative central to the Green Innovation Business Expansion (GR) Project, which is part of Toray's new medium-term management program "Project AP-G 2013" launched in April 2011.

Definition of Terms

Lysine: One of the nine essential amino acids that cannot be synthesized by the body and must be obtained from food or other sources. Ajinomoto produces lysine with plant materials through fermentation, mainly for use as an additive in livestock feed. Adding lysine efficiently compensates for nutrients that tend to be lacking in feed while contributing to the environment by reducing the excretion of nitrogen, which causes soil and water pollution and generates greenhouse gases.

1,5-pentanediamine (1,5-PD): A monomer (diamine) with five carbon atoms. In this joint research, 1,5-PD is produced from Ajinomoto's amino acid L-lysine through a decarbonation reaction and used as a raw material for biobased nylon.

Membrane-integrated bioprocess: The membrane-integrated bioprocess that Toray is currently developing consists of three processes: a membrane separation process for cellulosic sugars, a membrane-integrated fermentation reactor, and a purification system using a membrane.

The membrane separation process for cellulosic sugars is a technology to remove impurities such as fermentation inhibitors generated as by-products during the hydrolysis of cellulosic biomass. The process enables the recycling of the saccharification enzyme and the efficient concentration of target sugars for production of low-cost, high-quality celluolosic sugars. The membrane-integrated fermentation reactor is a cell-recycling, continuous fermentation reactor based on a highly chemically stable membrane that enables continuous production for longer periods at faster rates than conventional batch fermentation. The purification system using a membrane is an energy-saving technology for removing impurities from fermentation broth and removing water to concentrate fermentative chemical products.