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Articles from 2009 In July

Scientists Seek to Power Medical Implants with Piezoelectric Materials

University of Houston (UH; Houston) scientists are studying flexoelectricity in an effort to make piezoelectric materials that could be used to power such electronic devices as biomedical implants. Currently used in commercial applications such as gas lighters in homes and actuators, the research team hopes to use the materials to create an lightweight, environmentally friendly energy supply for nanodevices. Using their understanding of flexoelectricity, the team is experiementing at the nanoscale to make ordinary material exhibit the piezoelectric effect. Associate professor Pradeep Sharma and Ramanan Krishnamoorti, UH chair of the chemical and biomolecular engineering department, are working together to embed classes of nanostructures in polymers to create unusual types of piezoelectrics. The flexoelectric effect is mainly a function of size, and materials with nanoscale features exhibit a much larger flexoelectric effect, according to Sharma. "You can make the effect even larger [in materials that are already piezoelectric]," Sharma says. The piezoelectricity in barium titanate, for example, can be increased by 300% when the material is reduced to a 2-nm beam and pressure is applied, he adds. In addition to the challenge of fabricating these piezoelectric nanostructures, the team—and the technology—are hindered by the lack of methods for storing the electricity produced by the materials. The amount of power that can be harvested is still too low to actually power wearable devices, unless efficient electric storage solutions, like nanocapacitors, also are conceived, according to UH professor Ken White.

Medtronic Pays Hefty Sum to Abbott to End Stent Suit

Medtronic and Abbott have agreed not to sue each other over stent technology, thanks to Medtronic's offer to pay $400 million to Abbott. The settlement resolves all outstanding intellectual property litigation between the two medical device makers, who agreed not to sue each other again in the area of coronary stent and stent delivery systems for at least 10 years. Medtronic said it will also pay $42 million to evYsio Medical Devices as part of a sublicense to Abbott of evYsio's stent design. Medtronic expects to report a special charge against its first-quarter financial results for the settlement with Abbott.

Surface Acoustic Waves May Revolutionize Drug Delivery

Acoustic waves are created to form fluid jets.

Acoustic waves are used to form fluid jets.

Researchers at Monash University (Victoria, Australia) have been developing a novel method for forming a fluid jet from an isolated droplet. Led by Leslie Yeo, the team has harnessed surface acoustic waves (SAWs) to transport fluids, opening the door to revolutionizing medical device applications. Fluid jets are generally created by forcing a liquid through a small opening. But in microfluidics, it is challenging to manipulate small amounts of fluid because of high surface tension. Many microfluidic devices must be attached to a big pump, resulting in an unwieldy and inefficient device. Yeo and his colleagues hope that SAWs will overcome this limitation. Tiny versions of seismic surface waves, SAWs have amplitudes that can be just a few nanometers. In microfluidic applications, they can be used to vibrate and break up droplets. In their work with SAWs, the researchers put two electrodes on a lithium-niobate piezoelectric surface, a material that converts electric voltage into SAWs. Made from arrays of curved metal strips, or arcs, the electrodes took up two 90° sectors of a disk-shaped object with a hole in the center. The arrays focused SAWs from opposite directions into the center, which contained a 1- to 5-µl drop of water, ethanol, methanol, or octanol. At a frequency of 30 MHz, the vibrations triggered different behaviors in the droplets, depending on the vertical acceleration of the waves, which the team controlled with slight changes in amplitude. At smaller amplitudes, the force wasn't strong enough to overcome the droplet's surface tension, causing it to oscillate in place. At larger amplitudes, the droplet erupted into a jet 1 to 2 cm high, reaching speeds of several meters per second. The larger the SAW amplitude, the longer the jet. At even higher amplitudes, the jet broke up into a series of smaller droplets. The largest SAWs caused the droplet to form even tinier droplets, a process called atomization. The next step for Yeo and his team is to learn how to control the jets. Precise control may enable the technology to be used in future medical device applications such as drug delivery devices.

CDS Launches Medical Tubing Extrusion Equipment Line

The CDS downstream medical tubing extrusion line includes a vacuum sizing tank, cutter unit, and takeaway conveyor.

The CDS downstream medical tubing extrusion line includes a vacuum sizing tank, cutter unit, and takeaway conveyor.

Extrusion machinery provider Custom Downstream Systems Inc. (CDS; Lachine, QC, Canada) has launched a new line of downstream extrusion equipment for medical tubing applications. The line includes a high-precision vacuum sizing tank, a combination servo belt haul-off and servo fly-knife cutter unit, and a takeaway conveyor. Designed to provide the precise shaping requirements of medical tubing applications, the vacuum sizing tank, model CMPVS 8-8, features an efficient water cooling system and high heat-transfer rate. To maximize operator control and reduce downtime, the tank is constructed with exterior product-support rollers, retractable water reservoirs, and water-level adjustment functions. These features enable the operator to make adjustments to the machine without halting production. Horizontal and lateral movement of the tank is controlled by manual knobs, but the unit also allows three-axis movement via a PLC. The model CMCBSSK 2-125 combination servo belt haul-off and servo fly-knife cutter unit features cut-to-length and x-y cutter adjustment designed to provide high accuracy and pulling capabilities. It has a maximum cut length of 254 m, minimum cutting capacity of 0.254 cm, and offers a cut-to-length accuracy of ±0.03 cm. To ensure overall quality and consistency, the unit has an integrated lubrication system and the machine also includes an easy blade-replacement channel for operator safety. To efficiently collect extruded products, the model CMTC 4-10 takeaway conveyor is designed with an adjustable frame that has front-mounted controls, which allow for independent line speed adjustments within a 39-45-in. range. Such adjustment capability can reduce product-collection costs while increasing overall productivity, according to the manufacturer. Monitoring of the unit's speed is made easy with a control that indicates the conveyor's movement in feet per second. The machine also has a pneumatic ejector that discharges to a product collection tray and exterior ribbing designed to reduce the risk of residue accumulation.

Argotec Restructures TPU Film Business to Better Serve Medical Device Industry

Argotec's sterilizable TPU film products offer softness and breathability characteristics that make them suited for use in medical device and wound-care applications.

 TPU films offer softness and breathability characteristics that make them suited for use in wound-care applications.

To better serve the medical device and wound-care product manufacturing industries, Argotec Inc. (Greenfield, MA) has restructured its thermoplastic polyurethane (TPU) film business. The company is taking a more application-oriented approach to the way it bundles groups of like products and resources. "Instead of focusing just on products we can make and market, we are concentrating on better matching our film extrusion capabilities, technical expertise, and resources with the applications of our customers," says Bruce Wilby, Argotec president and CEO. Recognizing a trend among medical product manufacturers of increasingly using polyurethane films in conversion, fabrication, and pressure-sensitive adhesive coating processes, the company is highlighting the performance characteristics of its Argomed TPU products that are suited for those applications. Converters, fabricators, and manufacturers are specifying TPU film for medical device and wound-care products because of its high rate of moisture-vapor transpiration breathability, softness, and stretchability, according to the company. Available with antimicrobial infection control technology, the company says its TPU film and sheet products contain no plasticizers that can cause allergic reactions in patients or make a product more brittle, which can reduce its potential shelf life. Compatible with most commercial adhesive systems, the TPU films also can withstand multiple commerical cleanings as well as EtO, gamma, and autoclave sterilization. The company can extrude TPU in film and sheet thicknesses ranging from 0.2 to 125 mm and widths up to 86 in. The restructuring is also a response to customer requests for a film supplier that can act as a partner in solving specific application challenges. "We feel that the investments we have made in equipment, facilities, along with restructuring our business in a way that allows us to more effectively focus those resources on solving customers' design and production challenges, is a clear answer to that call," Wilby says.

Precision Medical Products Expands Cleanroom Services

Precision Medical Products offers portable Class 10,000 cleanroom services for injection molding applications.

Precision Medical Products offers portable Class 10,000 cleanroom services for injection molding applications.

Precision Medical Products Inc. (Denver) has continued to expand its cleanroom manufacturing and assembly services to include Class 100,000 and Class 10,000 capabilities since building its production facility four years ago. Customer demand has been driving the company's focus on such services, explains George Weaver, vice president of marketing. "More and more customers want to purchase a turnkey product including packaging and sterilization of their medical devices," he says. The company, which manufactures devices and needles for cardiovascular, orthopedic, drug-delivery, and other applications, offers molding and welding in addition to assembly and packaging services. It also can provide washing of components and assembled products and recently added simulation molding services for plastic and thin film applications. As demand for injection molding services has increased, the company also has made portable cleanroom manufacturing and packaging services available. "Mobile cleanrooms may be applied in manufacturing where cleanrooms don't exist," says Weaver. "It's a portable tool that we are using for specific injection molding operations that require a Class 10,000 environment."

Market Projections for Medical Devices

Here are the predictions the firm has made for several device segments. Cardiac Rhythm Management Devices:  $26.2 Billion by 2015 Drivers: The rise of the aging population and cardiac abnormalities Products: Pacemakers, internal cardiac defibrillators (ICDs), external defibrillators, and associated devices represent the largest segment of the cardiovascular devices market. Emphasis: Product safety and technological development. Market Leaders: Boston Scientific, Bard Electrophysiology, and Medtronic Inc. Gastrointestinal (GI) Endoscopy Devices Market: $2.52 Billion by 2015 Drivers: A rapidly aging population and increasing incidences of GI disease have made the endoscopes the most utilized diagnostic tool. Products: Growth is expected to occur in the area of techniques such as robotics, miniaturization and imaging, moving away from GI videoscopes. Emphasis: A prevention screening market will also contribute to growth. Market Leaders: Boston Scientific, CONMED Corp., Fujifilm, and Johnson & Johnson. Infusion Pumps Market: $6.8 Billion by 2015 Drivers: This market has been characterized by competition and cost containment efforts bearing from Group Purchasing Organizations; however, changing demographics, increased spending in healthcare and innovations in treatment have affected the market. The U.S. and Europe dominate this market. Products: Strong opportunities are present in the homecare sector, particularly with the development of chemotherapy drugs and equipment upgrades with more cost effective devices. The increasing incidence of diabetes worldwide, as well as other lifestyle factors, may contribute to market growth. Market Leaders: Animas Corp., Hospira Inc., Insulet Corp., and Smiths Medical. Carbon Dioxide Monitors: $294 Million by 2015 Drivers: The requirement for enhanced patient monitoring will drive this market, especially outside of operating rooms. Products: Emerging applications include critical care units, recovery rooms and post-anesthesia care units. Market Leaders:  B. Braun Melsungen AG, Datascope Patient Monitoring, Drager Medical AG & Co KG, and GE Healthcare Life Support Solutions. Mechanical Ventilators Market: $1.18 Billion by 2012 Drivers: Factors affecting growth in this market include the demand for new low-cost ventilators to replace equipment in mature markets. Emerging areas of Latin America and Asia-Pacific lead the way for growth though the U.S. remains the largest market. Products: The fastest growing segment is projected to be portable ventilators. Market Leaders: Companies leading the marketplace are Maquet, Covidien, Philips Respironics, and Spacelabs Healthcare. Nanomedicine Market to Pass $160 Billion by 2015 Drivers: The unique properties of nanoparticles and their ability to be used in the course of disease diagnosis and treatment offer a robust opportunity in this market. Products: The nanomedicine segment includes nanodrug delivery, nanoanalytical contrast reagents, nanobiomaterials and nanopharmaceuticals. Market Leaders: The market is fragmented but several key players are Abraxis BioScience Inc.; Crucell N.V.; Elan Corp. Plc; Nanosphere Inc. and Wyeth Pharmaceuticals.

Minnesota Sees Sizeable Slice of VC Funding

Despite the economic turmoil plaguing the nation, Minnesota's medical device industry has managed to nab a fair share of investment dollars in the second quarter, according to reports. Venture capital (VC) funding contributed $96.9 million to 10 local companies. Although significantly off-pace compared with last year, these figures demonstrate a promising upswing in investment from the $56.2 million received by five companies during the first three months of the year, states a MoneyTree report by PricewaterhouseCoopers and the National Venture Capital Association. Almost $75 million of the funds were funneled into medical device start-up companies, which is a dramatic gain from the first quarter. The biggest surprise from the report, however, is not the uptick in investment (although likely welcome), but in the companies that are receiving the funds. The Twin Cities have long been recognized as the heart of the cardiovascular device sector. But perhaps change is on the horizon in the form of diversification: Only one of the seven start-ups that received funding is currently working on a cardiovascular technology. Instead, investments went to companies developing products for such market segments as orthopedics, sleep disorders, neurological disease, wound care, and digestive disorders. "Most of the deals we've had in this town started with cardiovascular devices," Jay Hare, a Minneapolis-based PricewaterhouseCoopers analyst, told the Star Tribune. "But the cardiac market has matured; it's not quite the Wild West it used to be. We are starting to diversify into other areas of medical technology. That's encouraging, because it means Minnesota is apt to stay strong in the medical arena." Is Minnesota gearing up for a changing medical device landscape? We'll have to wait and see.

Clearer Vision in Pea-Sized Telescope

However, not every patient with age-related advanced macular degeneration is a candidate for the Implantable Miniature Telescope (IMT). According to one retinal specialist who has authored papers on the IMT, only about 20 out of 100 potential candidates will receive the device. Reasons for ruling patients out include eye shape and balance issues. The device has been approved in Europe, and VisionCare expects FDA approval later this year. In March, an FDA advisory panel unanimously recommended approving the implant.

Transducer Technology May Help Shrink Ultrasonic Cutting Devices

Researchers from three UK universities are developing a transducer technology that does not operate in resonance, allowing the design of smaller ultrasonic cutting instruments. The goal is to create devices that surgeons will be able to use to perform minimally invasive procedures on delicate areas of the body such as the spine. Current ultrasonic cutting devices consist of a Langevin piezoelectric transducer attached to a cutting blade that is tuned to resonate in a longitudinal mode at a low ultrasonic frequency. "The current systems have to be resonant, which means to maximize the vibrations you must create a device that is tuned to the frequency you're operating at," remarks Margaret Lucas, a mechanical engineer from the University of Glasgow in Scotland, who is leading efforts to develop the transducer." Once it is tuned, it dictates what size the device has to be." Because the length of the tuned blade must be designed a half-wavelength or a multiple of the half-wavelength of the frequency driving the system, cutting instruments based on this technology must be relatively large. To overcome this size issue, the UK researchers are developing ultrasonic cutting instruments that will incorporate flextensional transducers. A flextensional transducer consists of piezoelectric rings bonded to two endcaps. When a voltage is applied, the ring contracts radially and the endcaps flex, providing an amplified longitudinal motion. Lucas and her colleagues have proposed attaching the cutting blade to one of the vibrating endcaps, causing the blade to behave like a rigid body without having to be a tuned component of the device. "Basically it would not rely on being resonant," Lucas explains. "It takes away that limitation in terms of the size and geometry of the device." The researchers think that the blade of a cutting device based on a flextensional transducer can be tailored to provide better interaction between the blade and the bone than the current technology, resulting in more-accurate incisions. It will also allow the overall ultrasonic device to be miniaturized. "The devices will be used in orthopedics probably for spinal procedures and surgeries to the face," Lucas remarks. "There are a lot of procedures that currently cannot be accessed by minimally invasive methods, and we are hoping this will be possible with a small and very accurate ultrasonic device."