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Medical Product Manufacturing News
 

Archive for June, 2009

Sweetening Silver-Based Antimicrobial Coatings

Tuesday, June 30th, 2009

Known for its antimicrobial properties, silver is widely used in implantable device coatings to prevent bacterial growth and ward off infections. However, because of their cytotoxicity, silver nanoparticles have possible adverse effects on the body. Andrea Travan, a materials engineer at the Università degli Studi di Trieste (Italy), remarks, “So far, to the best of our knowledge, water-based biomaterials able to successfully combine antibacterial properties of silver nanoparticles with demonstrated absence of cytotoxicity have not yet been reported in the literature.”

To remedy this deficiency, Travan and his colleagues have conducted research into developing a noncytotoxic nanocomposite hydrogel material for antimicrobial applications based on the polysaccharide alginate and silver nanoparticles. This hydrogel appears to be nontoxic toward three different eukaryotic cell lines because the nanoparticles, immobilized in the gel matrix, can exert their antimicrobial activity by simple contact with the bacterial membrane without being uptaken and internalized by eukaryotic cells.

Relying on the simultaneous presence of a sugar-based bioactive polymer for cell stimulation and silver nanoparticles for antibacterial activity, the nanocomposite hydrogels developed by Travan and his team display antibacterial activity without being harmful to mammalian cells. “In our cytotoxicity studies we show how the lack of physical barriers to nanoparticle diffusion into cells determines their generalized bio-availability, with the risk of a massive uptake by eukaryotic cells, which eventually leads to their death,” Travan explains. “Conversely, the nanocomposite materials we have developed are able to solve the cytotoxicity problem by creating a gel structure that efficiently immobilizes the metal nanoparticles and ions within the material.”

In addition to their cytotoxicity, silver nanoparticles tend to aggregate, losing their nanoscale properties. Travan and his team have also conducted experiments using the branched polysaccharide chitlac (lactose-modified chitosan), which they say helps to form and stabilize well-dispersed silver nanoparticles with a mean diameter of about 35 nm.

Nanosized Assassins Whack Bacteria

Monday, June 29th, 2009

Staphylococcus epidermidis bacteria are known for attaching themselves to medical implants such as catheters and prosthetics, leading to infections in patients. Inside the body, the bacteria multiply on implant surfaces, creating a slimy, protective film that shields the colony from antibiotics. Studies show that up to 2.5% of hip and knee implants in the United States become infected, affecting thousands of patients, sometimes fatally.

Until now, there has been no effective antidote for infected implants. The only way to get rid of the bacteria has been to remove the implant. However, help is on the way. Thomas Webster, associate professor of engineering and orthopedics at Brown University (Providence, RI), and Brown graduate student Erik Taylor have created a nanosized headhunter that targets the implant, penetrates the bacteria’s defensive wall, and kills it. Published in the International Journal of Nanomedicine, Webster and Taylor’s research is the first time that iron-oxide nanoparticles have been shown to eliminate bacteria on an implanted prosthetic device.

To carry out the study, the researchers created iron-oxide—or “superparamagnetic”—particles with an average diameter of 8 nm. Because of iron oxide’s metallic properties, the particles can be guided by a magnetic field to the implant, while its journey can be tracked using a simple magnetic technique such as magnetic resonance imaging. In addition, previous experiments have shown that iron seems to kill Staphylococcus epidermidis.

When the nanoparticles arrive at the implant, they begin to penetrate the bacterial shield, a phenomenon the researchers attribute to “magnetic horsepower.” Webster explains that a magnet positioned below the implant produces a strong enough field to force the nanoparticles above to filter through the film and proceed to the implant. Because of their minuscule size, the particles penetrate the bacterial cells.

The researchers note that by injecting 10 µg of the nanoparticle agents, up to 28% of the bacteria on the implant is eliminated after 48 hours. Repeating the same dosage three times over six days destroys essentially all the bacteria, the experiments showed. The tests demonstrate that “there will be a continual killing of the bacteria until the film is gone,” Webster remarks.

The researchers plan to test the iron-oxide nanoparticles on other bacteria and then proceed to evaluating the results in animals.

Comco’s Microabrasive Equipment Can Deburr PEEK Implants

Friday, June 26th, 2009
Microabrasive blasting can be used to deburr small medical implant components without causing damage to the parts.

Microabrasive blasting can be used to deburr small medical implant components.

Microabrasive blasting equipment from Comco Inc. (Burbank, CA) can be used to deburr medical implants made of polyetheretherkeytone (PEEK). The biocompatibility and chemical resistance of PEEK make it suited for use in implant manufacturing. However, machining PEEK implants typically generates burrs that can be cumbersome and difficult to remove manually, according to the company.

The equipment supplier is offering its microabrasive blasting technology as an alternative to laborious manual deburring. The fine abrasive stream from a blaster can quickly deburr implants and implant components without damaging the small features machined into the parts. Using a soft abrasive, such as sodium bicarbonate, the equipment has the cutting effectiveness required to deburr parts without cutting or burning the surface, according to the supplier.

To determine the most-efficient microblasting method for a specific application, the company offers sample part testing services.

Jamestown Plastics Expands Two Facilities

Thursday, June 25th, 2009

Jamestown Plastics (Brocton, NY), a contract manufacturer specializing in thermoforming, is adding equipment to its two facilities in order to increase its capabilities. The expansion project includes installing a 3 x 4-ft single-station thermoformer at its plant in Brownsville, TX, as well as a 5 x 7-ft rotary thermoforming press at its Brocton headquarters. The company expects the single-station machine to increase its capacity by 15% and the rotary press will support existing product lines, increasing capacity by 25%. The company also anticipates increasing its workforce later this year.

“Everybody in plastics sees that the current economic downturn has resulted in a great deal of quality used equipment being available to the market,” says Jay Baker, president, Jamestown Plastics. “Companies like ours are adding used equipment now because those deals probably won’t exist a year from now.”

Each of the company’s facilities also houses a Class 10,000 cleanroom for plastic medical device manufacturing operations. In addition to components for medical devices, the company offers thermoformed packaging.

New Scale Offers Micromotor Developer Kits

Wednesday, June 24th, 2009
New Scale's developers' kits can help simplify integration of miniature linear motors and position sensors into medical devices.

New Scale's developers' kits can help simplify integration of miniature linear motors and position sensors into medical devices.

Motion systems provider New Scale Technologies (Victor, NY) is offering developers’ kits to help ease integration of its smallest linear motor and highest-resolution miniature position sensor into small medical devices. Featuring the company’s Squiggle piezoelectric micromotor and Tracker NSE-5310 miniature position sensor, the kits serve as reference designs for closed-loop OEM system integration. The DK series kits can help simplify evaluation and integration of these miniature motion technologies for such medical devices as microrobotic surgical tools, miniature digital microscopes for endoscopy, and point-of-care instruments. The kits also can be used to develop devices for automated disease screening, drug discovery, and industrial machine vision and distributed sensing applications.

In addition to the Squiggle and Tracker products, the DK kits include a slide assembly reference design tool for mechanical integration that demonstrates proper mounting, loading, and alignment. The kits also include a drive card with the company’s NSD-1202 motor controller application-specific integrated circuit (ASIC). The ASIC serves as an electrical reference design tool for use in various stages of development, from initial product evaluation to prototype development.

Powered by two AA batteries, each kit comes with the company’s Pathway software, which controls the kit via a USB interface that is connected to a PC. The software enables evaluation of the motor and sensor using a graphical user interface. It also allows a user to develop and test scripts using the scripting interface and provides the necessary ASCII codes that the OEM would need to use in its embedded system or microcontroller.

The Squiggle linear micromotor measures 2.8 × 2.8 × 6 mm, and the Tracker position sensor with on-chip digital encoding is offered in chip-on-board packaging as small as 3.9 × 2.5 mm. Both the micromotor and the magnetic sensor array provide 0.5 µm resolution.

Biological Fuel Cell Breakthrough Could Empower Medical Devices

Tuesday, June 23rd, 2009

Researchers at the University of Georgia (UGA; Athens) have developed a method for growing molecular wire brushes that conduct electrical charges. Made up of chains of thiophene and benzene attached to metal surfaces as ultrathin films, the brushes could lead to the fabrication of biological fuel cells that may one day power devices that interface with living tissue, such as pacemakers, cochlear implants, prosthetic limbs, and biochemical sensors.

“The molecular wires are actually polymer chains that have been grown from a metal surface at very high density,” remarks Jason Locklin, a UGA chemist who has spearheaded the research together with graduate students Nicholas Marshall and Kyle Sontag. “The structure of the film resembles a toothbrush, where the chains of conjugated polymers are like the bristles. We call these types of coatings polymer brushes. To get chains to pack tightly in extended conformations, they must be grown from the surface, a method we call the ‘grafting from’ approach.”

To make the polymer brushes, the scientists laid down a single layer of thiophene as the film’s initial coating and then built up chains of thiophene or benzene using a controlled polymerization technique. “This technique gives us the control to systematically vary polymer architecture, opening up the possibility for various uses in electronic devices such as sensors, transistors, and diodes,” notes Locklin. Ranging in size from 5 to 50 nm, the ultrathin films are too small to see, even with the aid of a high-powered optical microscope.

While flexible electronics is a large and growing area of research, it’s still in its infancy, Locklin says. “For example, we don’t yet understand all of the fundamental physics involved in how electrical charges move through organic materials.”

Supplier Offers Scientific Injection Molding

Monday, June 22nd, 2009

Helix Medical LLC (Carpinteria, CA) reports that it has begun to incorporate scientific injection molding (SIM) practices into its liquid silicone rubber (LSR) molding operations. Combining product design, tool design, material selection, and process development from the polymer point of view, SIM enables manufacturers to control critical process parameters to ensure that parts are optimally produced without defects.

Although the methodology has been in use for some time in thermoplastic injection molding, it is relatively new to LSR molding. By applying the SIM process to LSR products, the company claims that it can develop processes in which potential defects are identified before the validation stage, saving clients time and money.

Driven by reliable documentation and data collection, SIM provides higher yields, lower material consumption, and greater process robustness than conventional injection molding, according to the company. The application of SIM principles delivers better flow control and fewer visual defects while increasing part integrity.

“Scientific injection molding allows us to produce consistent product quality through process repeatability from machine to machine, part to part, and setup to setup,” remarks Edward Callahan, vice president and general manager of Helix Medical’s Gloucester, MA, operations. “This methodology has allowed us to provide the documented standardized processes and the quality assurance required to support our customers’ regulatory requirements. We deliver superior value for our customers and partners by investing the time up front during the development stage.”

National Safety Month: Work-Related Injuries Are Down

Friday, June 19th, 2009

In recognition of National Safety Month, the U.S. Bureau of Labor Statistics (BLS; Washington, DC) has released data on work-related fatalities and nonfatal injuries and illnesses. The data shows that the rates of fatal and nonfatal injuries have declined between 1992 and 2007. This data consists of the latest statistics available; preliminary data for 2008 will be released in August 2009.

From 1192 to 2007, the overall rate of fatal work injuries was down from 5.2 to 3.8 per 100,000 workers. The majority of workplace injuries and illnesses, however, do not result in fatalities. Total injury and illness incidence rates, as well as rates for cases serious enough to warrant days away from work, showed a decline between 2003 and 2007. Although rates of nonfatal injury and illness are on declining, the category of manufacturing industries showed the highest rate of incidence (5.6 per 100 full-time workers) compared with other categories, such as construction (5.4), trade and transportation (4.9), and professional and business services (2.1).

The BLS data reflects an assertion by the American Society of Safety Engineers (ASSE; Des Plaines, IL) that American manufacturers’ ability to maintain effective work safety and health programs is a factor in their increased share in the international marketplace. “U.S. manufacturers are doing a good job competing with international companies,” says Michael Coleman, ASSE manufacturing practice specialty administrator. “By not cutting safety and health programs in this economic downturn and by doing a better job through internal innovations, [offering] ongoing education and training, working smarter, and looking at automation innovations, U.S. companies are holding onto and gaining in market share worldwide.”

Citing a report released today from the Federal Reserve Bank of Philadelphia (Philadelphia) that states that the U.S. manufacturing sector has shown its best performance since September 2008, ASSE is stressing that, while companies are doing more with less, employers need to remember that workplace safety and health is not an area to cut from, according to Coleman. “In order to remain viable long-term, a company must maintain a solid safety process even through difficult times,” he says. “The most-successful companies also have the strongest safety performance.”

ASSE will be hosting its annual Professional Development Conference and Expo in San Antonio June 28–July 1. The event will feature a keynote address by U.S. Department of Labor secretary Hilda Solis, as well as education sessions and roundtable discussions.

Stopol Thermoforming Divisions to Operate as Thermoforming Machinery & Equipment Inc.

Friday, June 19th, 2009

As soon as the employee acquisition deal closes, the thermoforming and extrusion business divisions of plastics equipment dealer Stopol Inc. (Solon, OH) will operate under the name Themoforming Machinery & Equipment Inc. (TM&E; Solon, OH). The thermoforming and extrusion business divisions are being purchased by Don Kruschke, Stopol executive vice president. Scheduled to close in July, the deal is part of a restructuring of the company that is not expected to interrupt business operations.

The restructuring will enable Stopol’s business units—thermoforming, extrusion, injection molding, and auctions—to operate independently. Under the proposed plan, the auction business is expected to work with and support the new thermoforming and extrusion unit as well as the injection molding division. The decentralized structure will allow the units to improve their responsiveness to customer requests and reduce operating expenses, according to the company.

TM&E’s Web site is already live. In addition to information about the company’s thermoforming equipment, appraisal, and acquisition consulting services, the site offers thermoforming marketplace news and job listings. It also features a section for the company’s Society of Plastics Engineers (SPE; Brookfield, CT) thermoforming division that provides SPE news and serves as an online forum for discussing thermoforming technologies and issues.

NAMSA Offers Biocompatibility Seminar

Friday, June 19th, 2009

Contract research and safety evaluation organization North American Science Associates Inc. (NAMSA; Northwood, OH) is offering a two-day certification course on the biocompatibility of medical devices. Taking place August 11–12 in Orlando, the course is designed to provide participants with a working knowledge of biocompatibility, according to NAMSA.

Attendees who complete all activities on both days of the seminar will become certified as a biological safety specialist and will receive a certificate of completion. Offering a hands-on approach to understanding biocompatibility regulations, the course will cover how to analyze materials characterization data, perform risk assessment, and select and evaluate tests for developing biocompatible medical devices.

The company also is offering attendees the option of scheduling a free consultation with a NAMSA Advisory Services consultant following the seminar.