Originally Published January/February 2001
SHOWSTOPPERS
Testing equipment
A selection of innovative new products and services exhibited at MEDTEC (Amsterdam) and Micronora (Besançon, France)
Testing equipment combines portability, versatility
Accurate
and reliable testing is achieved even in space-limited settings with
a company's 5540 series of single-column biomedical testing systems,
which were displayed at the recent MEDTEC show in Amsterdam.
Weighing in at just 40 kg, the 5540-series machines can be used to test items such as tubing, syringes, catheters, stents, guidewires, sutures, and tissue samples. "The units are portable, quiet, and accurate," says Barnaby Weston, senior product support engineer at Instron Ltd. (High Wycombe, Bucks, UK), adding that their small footprint makes them suitable for bench mounting.
A single-column design simplifies specimen installation, while grips
and accessories face toward the operator to ensure ease of operation.
A selection of grips, fixtures, extensometers, load cells, and other
accessories can be added to test virtually any specimen, including
prostheses and implants. The 5540 meets or exceeds international standards
for tension, compression, shear, peel, tear, friction, and flexure
testing on a variety of materials and components. Available in three
load capacities (500 N, 1 kN, and 2 kN), the 5540 series can achieve
testing speeds between 0.01 and 1000 mm/min. Accurate and repeatable
results are ensured with precision load frames, ball-screw drives,
and force transducers, providing 0.5% accuracy down to 1/100th
of full range.
Novel respiration-monitoring card holds potential for OEM applications
As
his breath fogged up the bathroom mirror, the mist turning into droplets
of water, Hans Petterson, research engineer at Linköping University
in Sweden, had a revelation. "I realized that this phenomenon in combination
with fibre-optic technology could be used to measure respiratory functions."
Christer Jacobsson, vice president of Optovent OEM (Bromma, Sweden),
which markets the Respons respiratory monitoring system that resulted
from Petterson's research, demonstrated the product and explained
its OEM potential at MEDTEC.
Based on the principle that warm air condenses when it is exhaled onto a cold surface, Respons transmits a faint light via fibre-optic cable to detect the presence of water droplets. By monitoring changes in light, the elapsed time between breaths and their frequency can be accurately measured. If breathing ceases, an alarm sounds.
The finished device, which is approximately the size of a paperback book, is connected to a cable containing the fibre-optic components and a disposable sensor that is placed in the patient's nose and mouth. Respons is suited for monitoring patients during transportation, as well as in intensive-care units, says Jacobsson, because there are no motion artifacts.
Of particular interest for MEDTEC attendees were the "guts" of the system, the OEM card that Jacobsson feels has great potential in a number of applications where the precise and reliable monitoring of respiratory functions is critical. One such application is the timing of magnetic imaging procedures: the technology has been adapted to identify the optimal moment when the magnetic image can be "snapped." Other OEM applications are emerging as the company pursues its work with healthcare experts, notes Jacobsson.
Injection moulding
Benchtop moulding machine slashes operating costs
A
benchtop injection moulding machine offers precision, low-cost injection
moulding of engineered thermoplastics. The Minimolder 12/90HSP from
MCP Equipment (Stone, Staffs, UK) is a fully automatic injection moulding
machine designed for the manufacture of components from 0.02 to 12
g shot weight.
The Minimolder is designed to optimize the moulding of small parts and minimize waste. Steve Aaron, sales manager at MCP, explains that the machine uses both plunger injection and screw plasticizing to achieve high precision and a homogeneous melt. "The plunger is transducer controlled, so it achieves exact volumes," he says.
Both pneumatic and hydraulic models are available in horizontal or
vertical configurations. The machines feature a PLC-driven control
panel with a high-resolution, state-of-the-art colour screen allowing
for touch-sensitive setting of all moulding parameters. Moulding and
material recipes can be saved and recalled at the press of
a button.
Aaron explains that small moulding machines are well suited for medical manufacturing: "They're perfect for prototypes or small production runs, as they can use smaller, less-expensive tooling and have lower energy costs associated with them." MCP's machines were featured at the recent MEDTEC show in Amsterdam.
Testing equipment
Leak-detection unit tests plastic parts at high speeds
In
order to respond to the needs of manufacturers with high output rates,
Ateq Corp. (Les Clayes Sous Bois, France) developed a leak-detection
instrument designed for the testing of plastic parts. The Ioniq leak
detector saw its medical sector debut at the MEDTEC show in Amsterdam.
The Ioniq detects faults on the order of 10 µm and can test up to 10 parts per second. The instrument can be used for the detection of localized moulding faults, insufficient membrane thickness, or perforations. According to Ateq UK manager Hans Lepelaars, the Ioniq can be used on such products as pharmaceutical caps, plastic and insulating membranes, or any item made of plastic or rubber.
The unit operates by measuring the current flowing between a patented charged probe and a ground plate placed under the part to be tested. Reject levels are determined as a percentage of nominal voltage. The Ioniq has an integrated ionizing high-voltage generator, and includes eight inputs and outputs for PLC applications. The unit measures 420 ¥ 300 ¥ 160 mm and weighs 6.5 kg.
Surface treatment
Continuous coating process applied to stainless-steel needle tubing
Using
its proprietary continuous coating process, MCTec (Venlo, Netherlands)
has developed a line of coated stainless-steel tubes that can be supplied
in a range of diameters and lengths. The company announced its expanded
product line at the MEDTEC show.
"Our coating process is an alternative to conventional spray coating," says technology director Hans Hanssen. The benefits of continuous coating, according to Hanssen, include a uniformly smooth finish and a constant diameter. "And because it is a continuous process, we can treat spools of tubing that measure 5000 meters long," adds Hanssen. The treated metal tubing is suited for the fabrication of electrostimulation and hypodermic needles, PTCA hypertubes, and related devices. Needles are available in five different colours; they can be supplied straightened and in any length.
The company can coat both metal and plastic tubing with a layer
of PTFE to promote hydrophobicity, or with hydrogels to induce hydrophilic
properties. In addition, anticoagulants and other medications can
be added to the hydrophilic SlipSkin coating for localized
drug-delivery applications.
MCTec is a joint venture of cable manufacturer Belden Cable & Wire and Biomat, a division of the University of Maastricht holding company. The firm's core expertise resides in coatings for invasive medical devices.
Heating components
Miniature heated tubing flexes, bends, and heats efficiently
Moving
fluids can be heated up to 100°C with a company's heated polymer-tubing
assemblies. High temperatures can also be maintained as fluids move
from a reservoir to a point of use.
Freeflex heated tubing has a durable jacket over the wound heating element that allows tubing to bend, flex, or coil on equipment that moves. Freeflex can also be formed and routed around other system components in applications involving stationary equipment.
Medical applications for Freeflex tubing include testing and analytical equipment, microplates, clinical diagnostics, and equipment for surgical procedures. "Researchers often try to mimic body conditions at 37°C," says Richard Hartfelder, emerging markets technology manager at Watlow Electric GmbH (Kronau, Germany). "But in order to do that, they need temperature control," he says, adding that Freeflex heated tubing gives a fast and precise temperature response. The tubing is available with optional thermocouples or thermistor temperature sensors incorporated into the thermal system. Users can also choose leads to exit one or both ends of the tubing assembly. Standard tubing is offered in 1/32-, 1/16-, or 1/8-in. ID. Other sizes are available upon request.
Watlow manufactures heaters, sensors, and controllers. The company, which exhibited at the October MEDTEC show in Amsterdam, has been a supplier to the medical industry for more than 50 years.
Electronics
Switches supplied in electric, air, and infrared models
"We
do a quarter of our business in the medical sector," says Richard
Chatham, managing director at Herga Electric Ltd. (Bury St. Edmunds,
Suffolk, UK), "and 95% of our work is for OEM customers."
Chatham notes that the company's most recent line of medical-grade foot switches places a new emphasis on design. The switches can be supplied with an optional plastic guard that sits above the foot pedal and resembles an aerodynamic bicycle helmet. "Most foot switches look like an afterthought," says Chatham, "and we wanted to design something that suits the medical market." Herga's 6251 heavy-duty foot switches conform to the European norm of 240-lb weight bearing and have a life expectancy of 1 x 106 operations. The foot switches, which were displayed at the MEDTEC show in Amsterdam, also feature screw terminals and a self-lifting clamp for the attachment of flexible leads or wires. A choice of colours is available.
Also gaining in popularity are the company's air-operated hand and foot controls, which operate on the principle of air pressure completing an electrical circuit. The Hergair 6448 foot bellows is suitable for freestanding applications and can also be secured with a built-in mounting plate. Herga also supplies infrared hand controls for use with medical devices in home-healthcare settings.
Moulding services
Supplier of silicone rubber parts banks on LIM
A supplier of liquid-injection-moulded (LIM) silicone rubber parts, Seal Innovations B.V. (Ramsdonksveer, Netherlands) may have only been in operation since January 2000, but it can lay claim to more than two decades of experience. "I have been involved with the development of LIM technology for the past 20 years," notes company founder and R&D manager H. P. Resler, who attended MEDTEC. "It's a difficult material to process," he says, adding that expertise in the material and the manufacturing method comes at the price of "testing, testing, and retesting."
Liquid silicone rubber has a number of mechanical and physiological properties that make it suitable for use in the medical device arena. To ease processing of the material, Resler helped to develop a pump, moulds, and a cold-runner system that optimize the production of silicone parts and minimize postprocessing operations. The system, adds Resler, "works with all types of materials and is easy to change over."
Seal Innovations specializes in the production of parts weighing from 0.01 to 250 g in small to large quantities. The company's two production facilitiesa plant was established in Singapore in April 2000are equipped with injection, transfer, and compression moulding machines.
Optical equipment
Microscope accessory improves operator comfort and productivity
At
first sight, the ISIS device developed by Vision Engineering (Woking,
Surrey, UK) may not seem all that impressive. Exhibited alongside
the company's arresting Mantis and Lynx product lines at MEDTEC, the
eyepiece lacked visual flair. But as sales and marketing director
Mark Curtis points out, appearances can be deceiving. ISIS is not
your run-of-the-mill microscope accessory.
Designed to replace traditional eyepieces on mono, routine, research, and stereo microscopes, the attachment significantly improves the performance of conventional binocular microscopes through the use of Vision Engineering's multilenticular and expanded-pupil technologies. "Compared to the conventional binocular setup," says Curtis, "you can move your head back and forth and find your optimal working distance." In fact, the distance between the user's eyes and the eyepiece is increased by a factor of four compared to conventional instruments, allowing workers who wear eyeglasses to avoid physical contact with the microscope without enduring a loss in the field or quality of vision. Expanded-pupil technology dispenses with the requirement to precisely align the eye with the center of each eyepiece, adds Curtis. "You can move your eye around and look at the outer parts of the optical field without losing the full image area."
Another advantage of the ISIS system is the elimination of the effects of mouches volantes or "floaters" in the eye, tiny tissue fragments that float within the eyeball and hinder viewing with a microscope. The expanded-pupil principle prevents these elements from cluttering the image. "This eye defect is accentuated as you get older," notes Curtis, "and it affects a lot of highly qualified personnel in labs that need to constantly pull back from the microscope and blink their eyes to rid themselves of these clouds."
ISIS can be installed in seconds on microscope systems produced by Leica, Nikon, Olympus, Zeiss, and a host of other companies. "It's a low-cost alternative to our Lynx and Mantis machines, suited for companies that aren't ready to invest in a whole new system," explains Curtis, "but who are looking for ways to increase productivity and operator comfort."
IV components
Bi-injection-moulded parts reduce costs and defects associated with assembly processes
The
bi-injection moulding process reduces production costs by eliminating
assembly procedures, which can also help to minimize product defects.
For these reasons, Promepla S.A. (Monaco) has made a "substantial
investment in new moulding equipment for the manufacture of injection
sites," says Sandra Molinari, who fielded questions about Promepla's
new capability from its stand at MEDTEC. "The bi-injection process
requires a special mould, which is quite costly," she says, "but we
think the investment is worth it. We feel that this is the technology
of the future for plastic IV components." The surface of the moulded
component is extremely smooth, which reduces the possibility of bacterial
buildup," Molinari notes. The use of a thermoplastic elastomer in
lieu of latex sidesteps allergy issues, she adds. The products are
in the advanced prototype stage and are scheduled to be on the market
by the middle of 2001. The company will initially produce sites for
3.54-, 4.8-, and 7-mm- ID tubing.
Catheter-processing equipment
Tip-forming machine offers precision and repeatability
Developed
for tipping thermoplastic tubing, a semiautomatic production machine
is suited for processing size 2 to 10 French probe and catheter components.
The tip former was designed initially by Statice S.A. Etudes et Développement
for French device manufacturer Arthesys. "The company asked us to
come up with a machine that improved on what was available on the
market," says Alain Valorge, quality systems manager, who represented
the company at the recent Micronora show. "In particular, Arthesys
wanted greater precision and repeatability," he adds. The firm recently
gave Statice S.A. permission to market the product to other European
device manufacturers.
Key features of the tipping machine are its "displacement accuracy and precise and regular heating," notes Valorge. It has a maximum working temperature of 350°C, and supports local air cooling without a holding period. Manual or automatic cycles are run under a Windows interface, and parameters are entered on a touch screen. The machine is suited for processing 0.54-mm-OD tubing in a range of materials including LDPE, HDPE, polypropylene, EVA, PVC, polyurethane, and polyamide.
Surface treatment
Coating eliminates galling, reduces friction in metal devices
A
biocompatible coating designed to enhance the performance of stainless-steel
medical instruments and equipment increases the material's surface
hardness to 80 Rc. Developed by ME-92 Operations Inc. (Providence,
RI, USA), the coating is now available in Europe through ME-92 Operations,
a division of Delage Technologies S.A.R.L. (Chambéry, France),
which promoted its services at MEDTEC.
Suited for metal-to-metal, metal-to-bone, and metal-to-plastic applications, the coating eliminates galling and reduces surface friction, according to Delage's marketing manager for medical devices, Alain Noulhiane. It also resists corrosion, which typically occurs when products are sterilized or laser marked, he adds. The surface treatment process results in a platinum colour that can be modified for reflectivity, if required.
Delage also supplies a nonreflective coating with similar biocompatibility and hardness properties. This coating is specifically designed for use in laparoscopic and endoscopic instruments.




