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Articles from 2009 In October

Catheter-Cutting Machine Promises No Chads, No Burrs


An ultrasonic catheter-cutting machine from Rainbow Medical Engineering incorporates a vacuum system that collects waste material, preventing chads that can endanger patient safety.

In standard catheter-cutting operations, the waste material, or chad, may not completely detach from the tube, or it may detach but remain lodged within the catheter. If not detected during the manufacturing process, the chad can migrate into the patient. Addressing this issue, Rainbow Medical Engineering Ltd. (Letchworth Garden City, UK) has developed an ultrasonic catheter-cutting machine that incorporates a vacuum system for preventing chads from endangering patient safety. At the same time, the unit produces burr-free tubing edges. As a result of its breakthrough capability, the system has been crowned the Best Technology Application at the 2009 Plastics Industry Awards in London. Adopted by several manufacturers in Europe and the Asia/Pacific region, the technology uses a vacuum to collect chads, which are passed through an electronic counter. If an anomaly is detected, processing is halted automatically. The production cycle cannot be restarted until the faulty catheter has been physically removed. Data cited by Rainbow Medical show that 44% of hospital patients with an indwelling urinary catheter develop bacterial infections within 72 hours of catheterization. Infections occur in the tissue damaged by the catheter or can result from bacterial encrustation caused by burrs on the edges of the catheter apertures. Rainbow Medical's ultrasonic cutting system produces measurably smoother, burr-free edges on the apertures than conventional systems, according to the company.

Custom Devices Benefit from Cross-Collaboration

And these days, it's not just about the "occasional special design but [instead is about] the trend towards mass customization of your therapies in the market at large," said Staresinic during yesterday's Siemens Webinar, "Transforming the Business of Patient-Specific Medical Products." Staresinic said that having a strong IT platform for innovation, which remains a gray area for some medical device companies, involves using product lifecycle management (PLM) software. PLM links plan, development, manufacturing, and support processes together for manufacturers. Although many companies use such software, a study by the firm AMR Research shed some light on software adoption and how this can affect patient-specific design processes. Only 31% of respondents claim to be using PLM at least partial basis. By the end of 2010, nearly 90% of respondents will have at least evaluated the impact that PLM could have on their business. So, the question remains--what is the rest of the industry doing? Alex Winber, director of OrthoRecon Knees at Wright Medical Technologies, said using PLM software as part of a product development process allowed Wright Medical to advance its Prophecy knee implant from inception to launch in less than one year. Wright Medical used Siemens' PLM Software to develop the interface for the product. However, despite this success story, AMR Research's study found that there's a lack of clarity surrounding the roles of R&D and operations at companies, especially within companies that are focusing on developing patient-specific devices. Custom products are being seen as a way to differentiate a product portfolio in an increasingly competitive marketplace, and a strong, cross-functional relationship between R&D and operations is essential.

Polymer Could Help Patients with Prosthetics Experience Sensation

While prosthetic limbs have come a long way over the years, they still have a long way to go. Improvements in aesthetics and functionality have contributed to better end products; however, the ability for amputees to exercise neurological control over their artificial limb persists as the impossible dream. Studies recently conducted by the American Society of Plastic Surgeons (ASPS) involving the electrically conductive polymer PEDOT, however, indicate that such ambitious goals may be attainable. Surgeons at the ASPS Plastic Surgery 2009 conference last week shared their research, which demonstrated promise for providing patients with prosthetic limbs the ability to feel heat, cold, and touch. Results of the two studies suggest that PEDOT could be the key to stimulating and growing nerve fibers. In turn, patients could some day potentially move fingers independently, experience sensation, and apply enough pressure for improved lifting and grabbing, according to the surgeons. Nerve regeneration in a rat was achieved in one study by placing PEDOT in a tube with several additional biological and synthetic materials and grafting it to the specimen's severed leg nerve. As a result, new nerve fibers sprouted up and compensated for the nonfunctional ones. The second study centered on using PEDOT to generate an electrical charge to enable sensation. After attaching a cup filled with cells and muscles around the severed leg nerve of a rat, the surgeons ensconced the cells and muscle in PEDOT. According to the researchers, new blood vessels, muscle, and nerve fibers formed after 114 days. Furthermore, the surgeons detected electrical signals after tickling the rat's paw--an indication that sensation had returned. Read more about PEDOT's prominent role in potential medical products, especially in future electrodes.

Furious Lobbying Successful Against Proposed Device Tax

The Senate bill is expected to levy a fee of between $15 billion and $20 billion over a decade on device makers, reports the Wall Street Journal. According to WSJ, "The lower fee comes as big device makers like Medtronic Inc., St. Jude Medical Inc., and Johnson & Johnson have lobbied furiously against the Senate proposal. Their congressional allies from Minnesota, California, Massachusetts and elsewhere have barraged Democratic leaders with calls and letters." This new version is an excise tax imposed on the device at the point of sale, rather than levied by the prior year's market share, as the original tax proposed. The medical-device tax will bring revenue that Democrats have sought to ensure their proposals expanding coverage to the poor and to the uninsured won't add to the deficit.

BD to Acquire HandyLab

The combined technology will be marketed as the BD Max system. More details about the acquisition will be made during BD's fourth quarter earnings call next week.

Chip-Based Optical Devices Could Play a Future Role in Imaging and Identifying Diseases

When illuminated by laser light shining through a prism, a silicon chip coated with a gold film (center of apparatus) can pull particles out of a liquid solution flowing over the top. (Photo: Kenneth Crozier, Harvard University.)

When illuminated by laser light shining through a prism, a silicon chip coated with a gold film (center of apparatus) can pull particles out of a liquid solution flowing over the top. (Photo: Kenneth Crozier, Harvard University.)

Tiny chip-based optical devices that can attract particles out of a liquid using the force of photons could enable scientists to image and identify disease cells without the use of microscopes and lasers. Developed by a team of physicists at Harvard University (Cambridge, MA) led by Kenneth Crozier, associate professor of electrical engineering, these optical traps are designed to be integrated with microfluidic devices, some of which are currently in clinical trials for diagnosing cancer and monitoring patient response to therapies. Usually costing tens of thousands of dollars, traditional optical traps require powerful lasers and microscopes to focus light onto particles as small as a single atom. In contrast, photons can transfer their momentum to atoms, molecules, or cells, enabling physicists to control the particle's movement by holding it steady or by pulling on it to monitor its response. The Harvard group hopes to integrate these optical traps into microfluidic devices for sorting and imaging disease cells in the blood. The optical traps developed by Crozier and Harvard researchers Ethan Schonbrun and Kai Wang can trap particles as strongly as more-complex systems. Microfluidic chips shuttle cells around in a fluid and typically control their movements using physical barriers and variations in pressure and voltage. The Harvard team's optical traps can pull cells down to the surface of a chip for observation and then use them to sort the cells based on their identity. Using manufacturing techniques common to the semiconducting industry, the Harvard researchers patterned chips with two different designs. One design is a silicon chip patterned with a ring with a radius of five µm. When illuminated by a laser, light resonates around the ring, generating an optical force that can pull particles from liquid flowing above the chip. The other design consists of a chip patterned with arrays of 64 bull's-eye patterns. When illuminated, each of these can trap a flowing particle. Each pattern has the function of a confocal microscope and could be used to get a 3-D picture of a cell, Crozier explains. Crozier's team has developed a third design based on gold structures that can generate a form of light energy, or surface waves, called plasmons. When a smooth gold film is illuminated, the light couples to the surface in the form of plasmons, which generate forces that are very localized and strong. The Harvard researchers have shown that when long tapered gold films patterned on silicon chips are illuminated by light shining through a small prism, they can used to pull a particle down and then push it along the gold surface. By changing the angle of the light, the particle's speed can be controlled. This type of structure will be particularly useful for cell sorting, Crozier remarks. These types of systems might eventually replace clinical-laboratory devices called flow cytometers, says Holger Schmidt, professor of electrical engineering and director of the W. M. Keck Center for Nanoscale Optofluidics at the University of California, Santa Cruz. Today's flow cytometers use bulky optical systems to separate cells in blood samples based on their size and shape. Chip-scale optics could do the same thing, but as portable devices, they could be brought to a patient's bedside. These compact optical traps might be on the market in three to five years, notes Schmidt.

New Report Evaluates Medical Coatings

specialty-medical-coatings-prospectus-1_page_1 A report published by Applied Data Research (Amherst, NH) explores medical coatings, a growing and increasingly important part of the medical device sector. Based on a recently completed survey, Medical Coatings: Evolving Technology, Emerging Opportunities analyzes the impact of advances in medical coating materials and application technology on medical device design, development, and applications. Advances in coating materials and application methods are improving device profiles in important areas such as biocompatibility and biostability, according to Applied Data Research. The expanding use of medical device coatings is lowering the incidence of thrombosis and infection, creating new opportunities for device developers and for materials and manufacturing service suppliers. Because of their ability to safely and reliably satisfy treatment protocols and compliance goals, suppliers of coated devices will have a significant impact on the future of patient care. To reinforce the growing trend toward medical coatings, greater cooperation is required among designers, manufacturers, and developers. At the same time, first-line development concepts such as concurrent engineering and design for manufacturing are becoming the rule rather than the exception. For coatings companies, the ability to create strategic alliances with device designers and manufacturers will be essential for fully participating in the growth of this segment. Targeting medical market decision makers, device developers, healthcare marketers, and supply-chain participants that understand the role and impact of medical coatings on medical device technologies, the report focuses on a range topics: specialty coatings market dynamics, commercial medical coatings, medical coating performance factors, medical coating issues and design factors, profiles of branded specialty medical coatings, specialty medical coating market segment analysis, market factors, and market participant profiles.

Sebra Sells Blood Collection and Processing Division

Sebra (Tucson, AZ) has announced the sale of its Blood Collection and Processing division to Haemonetics Corp. (Braintree, MA). With the sale of this division, Sebra plans to concentrate on strengthening its Medical Technologies division and its offerings to the medical device industry. As part of this objective, Sebra will also focus efforts in the coming months on rebranding the company, which will entail the unveiling of a new name that reflects its role in the medtech marketplace. "We are focused on enhancing our existing products and services as well as offering new, innovative technologies and solutions to medical device manufacturing and biopharmaceutical companies throughout the world," according to a statement by the company. Specializing in catheter manufacturing equipment, the company's current product line includes the Saffire and Pirf systems in addition to a range of accessories. Sebra also provides a variety of engineering consulting services.

Power Cords Under FDA Scrutiny

to cause electric shock, interruption of therapy, device failure, and fires, which could lead to serious injury or death. The reports all involve Hospira or Abbott devices that have AC power cords with a black plastic bridge manufactured by the Electri-cord Manufacturing Company. The cords are used with a number of medical manufacturers, and  FDA is in the process of determining which specific medical devices may be affected. Investigations so far suggest that the problems are caused by the prongs of the power cords cracking and failing at, or inside, the plug. FDA warns that all users of medical devices should be aware of the wear and tear on power cords. The agency recommends that any users who find they have cords with the black plastic bridge between the prongs should look closely for bent or cracked prongs, visible burns on the outer sheath, black residue or excessive signs of use and damage.

Ultrafast Camera Opens the Door to an Array of Medical Applications

A 32 x 32 single-photon avalanche diode array has been fabricated using 0.8-µm CMOS technology.

A 32 x 32 single-photon avalanche diode array, a detector used in Megaframe's camera, has been fabricated using 0.8-µm CMOS technology.

An ultrafast high-resolution video camera developed as part of the EU-funded Megaframe project has paved the way for a range of medical applications. Capable of extremely rapid image capture, the 1024-pixel photon-resolution CMOS camera can detect a single photon at a million times a second, enabling it to record molecular processes in unprecedented detail. "We need this sort of detail because biomedical scientists are studying processes at the intracellular and molecular levels," explains Edoardo Charbon, coordinator of Megaframe. Scientists use techniques such as fluorescence lifetime imaging microscopy (FLIM) to see what is happening in biomedical processes. When a fluorescent material is introduced to the area of interest, its spectrum of emission and rate of decay can indicate the presence of particular molecules in the body. For example, a fluorophore known as Oregon Green Bapta (OGB-1) decays at a rate proportionate to the presence of calcium, which is an important indicator of neuron activity. It is possible to go inside neurons and look at their ion channels, Charbon remarks. "These are the channels that allow neurons to communicate with other neurons. And you can basically see the amount of calcium that is present. You can probe optically how neurons communicate with other neurons just by looking at the concentrations of calcium in real time." The process of determining calcium concentrations can be recorded in ultrafine detail thanks to single-photon detectors such as those used in the Megaframe camera. "Biomedical scientists could in principle use this microscopic information about calcium to learn about macroscopic conditions like Parkinson's, or Alzheimer's, or epilepsy," Charbon says. A promising technique is the combination of fluorescence imaging with magnetic resonance imaging (MRI). "In MRI you need very strong magnetic fields in the cavity where you are performing the imaging, up to 10 Tesla, but conventional fluorescence technology won't work in these conditions," says Charbon. In contrast, Megaframe's photo detector, the single-photon avalanche diode, has been tested successfully in fields up to 9.4 Tesla. "Thus, it can be envisaged to have a system where fluorescence-enhanced imaging and functional MRI may be used simultaneously," Charbon states. "This is very useful in a number of biomedical applications, where one wants to monitor the correlation between the presence of certain molecules in organs, such as the brain, and their function."