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FDA Has Fewer Inspectors and More Device Complaints

Meanwhile, reports from manufacturers about problem devices more than tripled during the same timeframe. Graphic

Medtronic and Abbott Settle Suit

Under the terms of the deal, the companies agreed not to sue each other in the field of coronary stent and its delivery systems for at least 10 years. Medtronic will also make a $42 million payment to evYsio Medical Devices, which is related to its sublicense to Abbott involving evYsio's stent design technology.

Biopsy Needle Delivers Tumor-Tracking Implant

Instead of relying on biopsies for additional information about tumors and their response to treatment, the monitors provide doctors with constant data. The device uses magnetic nanoparticles developed by a Harvard professor who is also a cofounder of the company that is commercializing the technology. The nanoparticles can detect biomarkers that could potential help doctors decide which cancer treatments are best for patients in the long run. The researchers also suggest that a second device could be used for releasing drugs.

Researchers Combine the Advantages of Organic and Inorganic LEDs

Stretchable LED display consists of an interconnected mesh of printed micro LEDs bonded to a rubber substrate. Photo by D. Stevenson and C. Conway, Beckman Institute, University of Illinois.

Organic light-emitting diodes (LEDs) can be formed on flexible substrates in dense, interconnected arrays--an advantage they enjoy over standard inorganic LEDs. But inorganic LEDs are brighter, more robust, and longer-living than their organic cousins. Now, scientists at the University of Illinois (Urbana-Champaign), Northwestern University, the Institute of High Performance Computing (Singapore), and Tsinghua University (Beijing) have devised a method for making inorganic LEDs that combine the features of both types of technologies. To overcome requirements on device size and thickness associated with conventional wafer dicing, packaging, and wire bonding, the researchers developed epitaxial growth techniques for creating LEDs with sizes up to 100 times smaller than usual. They also developed printing processes for assembling these devices into arrays on stiff, flexible, and stretchable substrates. As part of the growth process, a sacrificial layer of material is embedded beneath the LEDs. When fabrication is complete, a wet chemical etchent removes this layer, leaving the LEDs undercut from the wafer but still tethered at anchor points. To create an array, a rubber stamp contacts the wafer surface at selected points, lifts off the LEDs at those points, and transfers them to the desired substrate. "The stamping process provides a much faster alternative to the standard robotic 'pick and place' process that manipulates inorganic LEDs one at a time," explains John Rogers, professor of materials science and engineering at the University of Illinois. "The new approach can lift large numbers of small, thin LEDs from the wafer in one step and then print them onto a substrate in another step." By shifting position and repeating the stamping process, LEDs can be transferred to other locations on the same substrate. In this fashion, large light panels and displays can be crafted from small LEDs made in dense arrays on a single, comparatively small wafer. The LED arrays are interconnected using thin-film processing, Rogers remarks. Because the LEDs can be placed far apart and still provide sufficient light output, the panels and displays can be nearly transparent. The thin device geometries allow the use of thin-film processing methods for the interconnects, rather than wire bonding. The new process for creating ultrathin miniature inorganic LEDs and assembling them into large arrays offers the possibility of creating new classes of lighting and display systems with properties that cannot be achieved using existing technologies, such as see-through construction and mechanical flexibility. Applications for the arrays, which can be printed onto flat or flexible substrates such as glass, plastic, and rubber, include wearable health monitors and biomedical imaging devices. "Wrapping a stretchable sheet of tiny LEDs around the human body offers interesting opportunities in biomedicine and biotechnology, including applications in health monitoring, diagnostics, and imaging," Rogers comments.

Cables and Connectors

SPOTLIGHT

Cables and Connectors
Connectors for medical applications

A series of connectors can operate in temperatures from –270° to 200°C, making them suitable for medical applications ranging from cryogenic processes to imaging equipment, including CT scanners, MRI systems, and ultrasound machines. While many connectors contain silver-plating material, these connectors are designed with a combination of nickel and gold materials for use over a wide temperature range. The MDM-series micro-D, MDMA-series rectangular microminiature, and MTB1-series single in-line microminiature connectors feature a twist-pin contact system, which provides a secure base for the contact and exhibits better electrical and mechanical characteristics than traditional machined or stamped contacts, according to the company. The D*M and D*MA D-subminiature connectors are offered with coaxial, power, or high-voltage contacts. Employing nonoutgassing and nonmagnetic materials to eliminate distortion in imaging equipment, the connectors are configured for board-to-board, board-to-cable, and cable-to-cable functionality.
C&K Components
Newton, MA
ck-components.com


Intelligent connector system

A connector system with integrated firmware helps prevent misuse of medical devices. SmarTrack controls information embedded into a connector such as product identification, serial number tracking, stored and retrievable calibration data, and the number of times the device has been used. It also offers a method for embedding microprocessor intelligence into a connector. The intelligent connector system can be used on any of the company’s connectors to indicate whether the device is for one-time or multiple deployments. The system’s counter also makes it suitable for use when third parties refurbish or sterilize devices, guaranteeing quality and safety. The connector system comes with a data loading module, a graphical user interface, and an application guide
Fischer Connectors
Alpharetta, GA
www.fischerconnectors.com


M12-style connectors

Similar to M12-style connectors, a line of connectors utilizes modified screw- and bayonet-locking mechanisms. Featuring a positive clicking mechanism that indicates when the connector is securely locked, the XS5 connectors also sport the Smartclick feature. This one-touch bayonet-locking system enables connection with a one-eighth turn. In addition to these features, the connectors mate with existing screw-type M12 connectors and offer ingress protection to the IP67 standard. The components provide better connections than screw-type connectors, according to the manufacturer.
Omron Electronic Components LLC
Schaumburg, IL
www.components.omron.com


Medical cables and connectors

A contract manufacturer specializes in the custom design, molding, and assembly of medical connector and cable systems. In addition, the company provides a range of standard products. Offering designs for the electroencephalography (EEG), electromyography, nerve integrity monitoring, polysomnography, electromuscular stimulation, and electrocardiography markets, the company provides cable designs that are certified to ISO standards. Cables include single- and multipin TouchProof safety plugs and jacks, snap and tab electrode clips, EEG cups, bar and digital ring electrodes, multipin yokes incorporating safety connectors, miniature two- and three-pin connectors that are typically used for hearing enhancement, and round and D-sub multipin connectors for standard machine connections.
Plastics One Inc.
Roanoke, VA
www.plastics1.com


Push-pull connectors and cable assemblies

Push-pull connectors offer medical device manufacturers a self-latching coupling mechanism with quick, reliable mating and vibration protection in a compact, high-density package. Offered in standard and water-protected versions, the push-pull JBX- and JKX-series connectors are available in a range of shell styles, materials, contact layouts, and configurations for outside-the-box quick-mate application. In addition to its selection of connectors, the company provides medical cable assemblies, from concept to final product. The supplier is equipped to handle small to high-volume runs, customization requests, overmolding, and cable assembly testing.
Souriau USA Inc.
York, PA
www.souriau.com


Miniature interface block
66273.tif
Utilizing industry-standard dual-density connectors in a metric-threaded 8-mm sealed unit to achieve remote device connections, a miniature interface block combines flexibility, serviceability, and high-density connectivity. By incorporating passive technology, the Multiple Interface Block (MIB) concentrates signals into one homerun cable, enabling the MIB to be remotely mounted with the devices and carry the signals back to the control system via a cable-out or quick-disconnect cable. Passive technology allows each point to be used as an input or output that can carry up to 2 A per contact with a 6-A total current. The dual-density connectors allow for two signals per remote device.
Balluff Inc.
Florence, KY


Modular plug and receptacle connector
66270.tif
Providing the interconnection room necessary to expand as design requirements change, a two-part modular plug and receptacle connector system has contacts that are laid out in four or five rows on a 2-mm pitch rather than in three rows on a 0.1-in. pitch. Part of the Tempus line, the CBC 20 connector system not only affords customers the ability to expand with each application size requirement, but it also allows engineers to manipulate large amounts of data at high speeds in the cable harnessing layout. The cable receptacles include all components needed to assemble finished cable ends. The four-row versions provide 4 × 6 and 4 × 12 contacts, while the five-row versions are available in 5 × 6- and 5 × 12-contact versions. The receptacles accommodate AWG 24 to 30 wire sizes with an insulation displacement contact, which offers quick termination without the need for wire stripping.
ITT Interconnect Solutions
Santa Ana, CA


For more information on cables and connectors, go to www.devicelink.com/mpmn/electronics.

Copyright ©2009 Medical Product Manufacturing News

In Brief

NEED TO KNOW

In Brief

Stock and custom stainless-steel component supplier Eagle Stainless Tube & Fabrication Inc. (Franklin, MA; www.eaglestainless.com) has achieved ISO 13485:2003 certification....DuPont (Richmond, VA; www.dupont.com) is merging three of its business units under the name DuPont Protection Technologies. Bringing together nonwoven and fiber technologies and protective apparel products, the merger combines DuPont Advanced Fiber Systems, Nonwovens, and DuPont Personal Protection....Horizon Die Company, Inc. (East Dundee, IL; www.horizondie.com), a supplier of precision dies, lead frames, and metal stampings, has recertified its operations to ISO 9001:2008 standards….Contec Inc. (Spartanburg, SC; www.contecinc.com), a supplier of contamination-control products for cleanroom and critical environments, has announced an agreement to purchase the Anticon Products wiping cloth business from Milliken & Co. (Spartanburg, SC; www.milliken.com)....Machine-tool technology supplier Mazak Corp. (Florence, KY; www.mazak.com) has launched a Virtual Technology Center online resource that provides machine demonstrations, application training, Q&A sessions, and a video resource called MazakTV that offers channels for industry segment content, engineering insights, and machine information.

Copyright ©2009 Medical Product Manufacturing News

Antimicrobial-Infused Polymer Demonstrates Backbone

NEED TO KNOW

Antimicrobial-Infused Polymer Demonstrates Backbone

Bob Michaels

Implants often rely on antimicrobial coatings to prevent infections. But the release of antibacterial agents via diffusion from a biomaterial’s surface may not be the most effective approach for combating biofilm formation on implants. With this in mind, Interface Biologics (Toronto; www.interfacebiologics.com) is developing a technology platform that it claims will prevent biofilm formation more effectively than coatings, last longer in the body, and kill a broader spectrum of microbes.

In development since 2002, the company’s Epidel platform differs from traditional antimicrobial technologies in that it is not applied to the surface of a device. “What makes it unique is that the antibiotic is actually not admixed into the polymer matrix, but is an integral part of the polymer,” explains Frank LaRonde, senior scientist at Interface Biologics and Epidel team leader. “It’s part of the backbone of the polymer. What that gives you is a polymer that is able to degrade over a longer period of time, providing the pharmaceutical that you have incorporated into that backbone.”

Surface coatings tend to release antibiotics too rapidly, failing to reduce the frequency of infection, according to the company. In contrast, Epidel’s polymer chemistry degrades in the body in the presence of enzymes that are generated by inflammatory white blood cells. Once healing occurs, the level of enzyme production decreases, slowing the release of the antibiotic. The release of the drug occurs from within the polymer to counter the formation of biofilm and the incidence of infection.

Longevity also sets Epidel apart from silver-based antimicrobial coatings, notes Tom Reeves, Interface Biologics’s president and CEO. Tests have shown that after 90 days, 90% of the polymer and 90% of the drug are still present. Silver-based coatings, on the other hand, tend to last in the body approximately 15 days maximum, according to LaRonde. “We’ve done benchmark studies with a number of silver-based products and our products. And in the experiments we ran, the silver gave up after one to three days.”

“There are a lot of people that have silver-based [coating] technologies,” Reeves adds. “Those are primarily for coating a catheter, a lead, or something like that. The makeup of this product is such that it’s unique in terms of the release profile and the ability to kill a broad range of bugs with a much lower concentration of antibiotics than you would normally have to use.”

The technology also has the unique ability to be spun into fibers. “Because the material is a polyurethane, we can make it any molecular weight of that polymer that we want,” LaRonde says. “We can make polymers that have the ability to be spun into fibers, giving rise to a number of different applicable areas, such as sutures.” As a spun fiber, the material can potentially also be used to manufacture dialysis cuffs, wound dressings, hernia mesh, and other medical devices.

Still in development, the technology platform for use with a urinary catheter could hit the market in 2011, according to the company. “The time frame for the fiber applications of Epidel won’t be too far beyond that,” Reeves says.

Copyright ©2009 Medical Product Manufacturing News

Neurosurgery Researchers Have Microelectrodes on the Brain

NEED TO KNOW

Neurosurgery Researchers Have Microelectrodes on the Brain
Stephanie Steward

Neurosurgeons at the University of Utah have developed tiny electrocorticography (ECoG) arrays that, unlike currently used ECoG electrodes, do not penetrate the surface of the brain.
Photo courtesy University of Utah, Department of Neurosurgery
Doctors at the University of Utah (Salt Lake City; www.utah.edu) have put on their thinking caps to find a better way of performing electrocorticography (ECoG)—the science of sticking electrodes onto the brain to record electrical activity from the cerebral cortex. Invasive and risky, ECoG has been used to develop devices that help treat epilepsy or allow people to control prosthetic limbs. But the Utah scientists have been working on enhancing microsized versions of ECoG electrodes to create grids that can be set on top of the brain’s surface instead of inserted into it. Though it still requires going inside the skull, the less-invasive method of using micro-ECoGs could potentially be used for cognitive and mood disorder treatment, drug screening and development, and neuroscience research.

“I see micro-ECoG as a disruptive technology that will eventually displace the currently used ECoG grids,” says Bradley Greger, assistant professor of bioengineering at the University of Utah and coauthor of the Journal of Neurosurgery study on the technology. “By using large numbers of microelectrodes, we are trying to match our sensor, the micro-ECoG grid, to the fundamental unit of neural signal processing, the cortical column, so that we can maximize the amount of information extracted from the brain while minimizing the level of invasiveness,” he explains.

Greger says that he and his coauthor, neurosurgeon and University of Utah assistant professor of neurosurgery Paul House, have learned a lot about the design considerations for the microelectrodes based on their initial experiments. The grids used in the published study were made of fine platinum wires that were then embedded in a layer of silicone. “These are the same materials used in the clinical ECoG grids currently used for localizing seizure foci,” says Greger. “Since these grids were very similar to FDA-approved grids—except for the electrode size—we didn’t have any strong biocompatibility concerns.”

Going from a large, low-impedance electrode in the standard ECoG grids to the very small high-impedance electrodes in the micro-ECoG grid did present electromagnetic interference issues, however. “Basically, you pick up a lot of dreaded 60-Hz electromagnetic resonance,” explains Greger. “We addressed this by adding local low-impedance references and having their wires follow the same pathway as all of the signal wires.” They also are working to develop shielded and impedance-converting cables for use in their next set of experiments.

“The key to all of this is to be able to use lithography fabrication techniques to reduce costs and increase quality and control over design parameters,” Greger says. “Another important issue is being able to handle the larger amount of data generated by the micro-ECoG grids.” To address this issue, Greger and House are currently working with Blackrock Microsystems (Salt Lake City; www.blackrock.dreamhosters.com) to develop the software and analysis tools necessary to take advantage of data gathered by the micro-ECoG electrodes and reduce them to outputs that are useful to clinicians. With such tools, the scientists hope to see lithographic parylene micro-ECoG grids become available in the next few years.

In the meantime, the investigators are aiming their efforts at examining real-time movement decodes and developing real-time algorithms for detecting and classifying arm and finger movements for prosthetic applications. “That is, can we determine at any given moment if a patient wants to move their arm and, if so, in what direction it is going to be moving?” asks Greger.

There is some debate among scientists as to whether prosthetics should be controlled from nerve signals collected by electrodes in or on the brain, or by electrodes planted in a residual limb. For Greger, it’s all about getting the maximum amount of information out of the nervous system with the minimum amount of risk. If a patient can control a prosthetic limb using an electrode in a peripheral nerve, he says, then that is probably the right approach. However, some patients may not have any functional peripheral nerves, or it may not be possible to extract enough information from them. These patients can only benefit from a neural prosthetic device that can interface directly with the cerebral cortex, he explains. “Patient and clinical need should always drive device design.”

Copyright ©2009 Medical Product Manufacturing News

3-D Nanoboxes Could Lead to 'Smart' Nanoparticles

While 3-D patterning on the macroscale is a breeze, 3-D fabrication on the nanoscale is extremely limited, according to researchers at Johns Hopkins University (Baltimore). A self-assembly technique developed by the scientists, however, has enabled the creation of nanoparticles with nanolithography-patterned 3-D surfaces. Hailing from the university's departments of chemical and biomolecular engineering and chemistry, the research team has built on established 2-D lithography patterning methods to produce stable 3-D polyhedral nanoparticles as small as 100 nm. To make the boxes, the team carved the outline of six , 500-nm-wide square panels into a silicon wafer to form a cross-shaped mold. A nickel film was then deposited in the mold in order to make the box's sides; tin grains were added to form hinges. Self-assembly of the panels into the cube shape was incited through the application of gases intended to etch away the silicon. Heating the panels then caused the hinges to melt, consequently merging the grains together and prompting the panels to be pulled upward to form the 3-D box shape. This capability could contribute to the development of future electronic nanocircuits or have application in drug-delivery systems, according to the researchers.

Manufacturing Advance Purifies Carbon Nanotubes

BREAKTHROUGHS

Manufacturing Advance Purifies Carbon Nanotubes
Stephanie Steward

SCNTE’s carbon nanotubes are made through a process that does not use metal catalysts, thereby eliminating metal impurities.
Experts anticipate that carbon nanotubes (CNTs) will play a major role in a host of next-generation medical device technologies, including a variety of sensors for drug-delivery, in vivo, and other applications. But despite the possibilities that CNTs present, they also have a major drawback: They are typically made using techniques that can result in the formation of electrochemically active metal impurities, such as iron and cobalt, that can compromise end products.

Sustainable Carbon NanoTechnology and Engineering Ltd. (SCNTE) is devoted to ridding CNTs of metal impurities. To that end, the company has developed a proprietary solid-state carbothermal conversion process for fabricating CNTs that does not use metal catalysts. SCNTE’s material is also more consistent than standard CNTs, which aids in the development of reliable sensor platforms, the company says.

“Carbon nanotubes are always contaminated with transition metal catalyst particles,” explains Bill L. Riehl, SCNTE COO. Such particles are a by-product of such manufacturing techniques as arc discharge, laser ablation, and chemical vapor deposition. Without undergoing extensive postfabrication purification, CNTs with these impurities pose problems for medical devices. “These particles are, at the minimum, inconvenient for analytical and medical or biomedical use,” Riehl notes. “More typically, their presence severely restricts the use of the material for medical applications due to large quantities of iron left from production.”

Because of the presence of metal catalysts, conventional CNTs cannot be used in such sensor applications as drug-delivery devices without major advances in device technology, Riehl remarks. “Residual metal catalysts interfere with sensor signals and often lead to false positives or negatives due to their residual chemical and electrochemical activity.”

But in their purified state, CNTs can play an important role in future sensor applications. The electronic properties of CNT-based materials promote the electron-transfer reaction of many biologically significant species. This capability, in turn, aids in the detection of these substances.

Based on its high-purity carbon nanotube material, SCNTE is developing an implantable glucose oxidase biofuel cell to power in vivo sensors. The material may also find its way into CNT-array sensors for detecting homocysteine, elevated levels of which serve as a marker for cardiovascular diseases and diabetes. Incorporated into paste electrodes, CNTs enhance the voltammetric sensing of homocysteine, which holds promise for future glucose testing. Riehl concludes, “The detection of homocysteine will be the new glucose test.”

Sustainable Carbon NanoTechnology and Engineering Ltd.
Kettering, OH
www.scnte.com

Copyright ©2009 Medical Product Manufacturing News