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Medical Product Manufacturing News
 

Archive for October, 2009

Heat-Shrinkable Polymer Leads to One-Size-Fits-All Microfluidic Chip

Friday, October 30th, 2009

New Scientist reports that a team of French researchers from the Claude Bernard University (Lyon, France) has developed a “print ‘n shrink” technology that offers increased flexibility in the fabrication of microfluidic devices.

Current fabrication methods can limit design freedom, according to Christophe Marquette. a biochemical engineer involved in the project. The team also identified associated costs and difficulty level as additional drawbacks to established techniques. In an attempt to resolve these issues, the French scientists opted to diverge from traditional approaches. Instead, rather than trying to precisely etch the channels onto a substrate at the targeted diminutive size, the team experimented with shrinking the chip.

In their studies, the scientists were able to apply the desired microfluidic channels and patterns onto a 230-µm-square chip made from the heat-shrinkable polymer PolyShrink. Warming the PolyShrink chip prompted it to minimize in size; in turn, the thickness increased. Ultimately, the team was able to shrink the chip to 100 µm square while achieving a thickness increase from 15 to 85 µm. Because the features and channels maintained their dimensions throughout the process, the researchers believe that this method could provide more flexibility and potentially cut costs for manufacturers of microfluidic devices.

Read about another innovative approach to microfluidic device manufacturing by a savvy student from the most-recent issue of MPMN.

Catheter-Cutting Machine Promises No Chads, No Burrs

Thursday, October 29th, 2009
catheter-cutting

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.

Polymer Could Help Patients with Prosthetics Experience Sensation

Wednesday, October 28th, 2009

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.

Safety Study Indicates Viability of Nanoscale Electrodes for Neurological Devices

Tuesday, October 27th, 2009

As companies and universities invest an increasing amount of R&D hours and dollars in nanotechnology, speculation about the safety of the burgeoning technology for biomedical use has similarly been on the rise. In an effort to gain clearer insight as to how nanoparticles interact with the body, a team of Swedish scientists conducted experiments on rats to evaluate the effects of injected nanowires on their brains. Observing that there were only minor differences between the brains of the test and control groups after 12 weeks, the team has concluded that the development of nanoscale electrodes could be a biocompatible and viable option for future neurological applications.

The development of safe nanoscale electrodes could enable the advancement of neurological devices designed for the treatment of Parkinson’s disease and chronic pain, for example.  Researchers believe that such tiny electrodes could register and stimulate the most-minute parts of the brain for improved and targeted care. However, the impact of the nanoelectrodes on the body if they disconnected from their contact points has remained a mystery and point of concern. The researchers from Lund University (Lund, Sweden) joined forces to investigate this mystery by assessing the consequences of a potential worst-case scenario associated with the implantation of nanoscale electrodes.

To do so, the scientists injected rats’ brains with nanowires similar in size and shape to the registration nodes of proposed nanoelectrodes. The injected rats were then evaluated after 1, 6, and 12 weeks to study how their brains were reacting to the foreign nanowires.

“We studied two of the brain tissue’s support cells: On the one hand, microglia cells, whose job is to ‘tidy up’ junk and infectious compounds in the brain and, on the other hand, astrocytes, who contribute to the brain’s healing process,” notes Nils Danielsen, a researcher involved with the project. “The microglia ‘ate’ most of the nanowires. In weeks 6 and 12 we could see remains of them in the microglia cells.” Results indicated that permanent brain damage or injury was not sustained by injecting the nanowires. The researchers believe that this biocompatibility study could help to encourage progress in the development of nanoelectrodes.

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

Monday, October 26th, 2009
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

Friday, October 23rd, 2009

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.

Texcel and Circle Medical Merge

Thursday, October 22nd, 2009

Circle Medical Devices (Los Gatos, CA) and Texcel Medical (Springfield, MA) have merged to form a new business venture dubbed Cirtec Medical Systems. The company will focus on providing solutions for the design and manufacture of medical devices.

The new company will capitalize on the strengths of both companies. Texcel, for example, specializes in the design and development of orthopedic, implantable, cardiac-assist, interventional, and combination devices. Circle Medical offers experience in contract design and engineering services, including software, mechanical, and electrical engineering capabilities. It has collaborated on a variety of medical products such as combination and drug-delivery products, cardiovascular implants, and diagnostic instrumentation.

“Cirtec Medical Systems combines the strength of Circle Medical’s extensive design and development capability with Texcel Medical’s exceptional development and manufacturing,” says Barry Smith, Cirtec CEO. “This strategic union creates a strong, technically driven, 130-person full-service medical device engineering and manufacturing industry resource that is deeply experienced across all therapeutic categories. Moreover, our team has particular expertise in minimally invasive systems, active and passive implants, and medical electronics.”

Cirtec Medical will operate from Texcel’s Massachusetts facility and Circle Medical’s plants in California and Minnesota.

Sebra Sells Blood Collection and Processing Division

Wednesday, October 21st, 2009

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.

Ultrafast Camera Opens the Door to an Array of Medical Applications

Tuesday, October 20th, 2009
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.”

Spider Webs May Mimic Muscles and Serve as Future Medical Device Material

Monday, October 19th, 2009
spider-web

A plastic weight is suspended from a single spider silk thread and subjected to the changes in relative humidity shown in each frame. The initial increase in humidity resulted in a large displacement during supercontraction. Subsequently, the silk thread lifted the 9.5 mg weight through seven drying cycles. The average displacement during each contraction was 0.65 mm, or 1.7% of the thread’s total postsupercontraction length. (Image courtesy of the Company of Biologists.)

With toughness, extensibility up to 30%, and tensile strength about five times stronger than that of steel of the same density, spider silk is being investigated by researchers interested in harnessing the material’s mechanical properties to make a range of future medical products—from adhesives and sensors to drug-delivery devices. But researchers are also interested in spider silk’s cyclic contractions, which are controlled by changes in humidity. This property may eventually enable scientists to use the material to mimic muscles.

Todd Blackledge, a researcher in the biology department at the University of Akron (OH), found that by restricting a 5–µm-diameter spider silk thread in a force machine and cycling humidity levels, the silk could exert a cyclic force. “I felt that this cyclic humidity response could be an interesting approach to design biomimetic muscles using spider silk,” remarks Ali Dhinojwala, professor in the department of polymer science at the University of Akron. “We made a slight modification in our experiments. Instead of restraining the spider silk on a force machine, we decided to hang weights. Interestingly, as we cycled the humidity, the weight was lifted up and down in response to changes in humidity.”

The calculations by Dhinojwala and Blackledge’s team indicate that silk generates work 50 times greater than the equivalent mass of human muscle—a much better result than most synthetic materials developed so far. “It is intriguing that we can do this by changing only humidity instead of all the complex electrical power–based muscles that researchers have been working on,” Dhinojwala says.

The researchers believe that the magnitude of the stress generated by spider silk is directly proportional to changes in humidity. The total force generated increases as fibers are bundled together. The cyclic contraction of spider silk can produce work that is sufficient for a single 40-mm long, 5-µm diameter fiber to lift at least 100 mg. The lifting response occurs within 3 seconds of the change in humidity. “We have been achieving a strain (or change in length) of about 2%, and we need to design strategies to amplify this strain” says Dhinojwala. “But we are confident that the potential limitation of lower strain can be overcome by using larger lengths of silk, or through strain amplification.”

Demonstrating the use of dry and wet air to control the contraction and relaxation of spider silk and silkworm fibers, the scientists hypothesize that water molecules cause a general swelling of the silk, and their removal during drying results in contraction. “This is strikingly similar to the mechanism proposed to explain how plant tissues can act as motors—actively expelling seeds from the parent plant and even burying seeds in the ground,” Dhinojwala explains. “Thus, cyclic contraction of spider silk may result from a relatively general response of biological tissues to humidity.”

The scientists emphasize that they are more interested in the potential applicability of silk as a biomimetic muscle than in the causes of the cyclic contraction. They foresee that silk engineering could perhaps serve as an attractive technology for future lightweight biomimetic muscles.