Originally Published MPMN September 2001
Originally Published MPMN September 2001
Spotlight on Catheter Processing
PVC catheter production system
PVC catheter pilot and production equipment uses a dipping-system technology that allows numerous product types to be manufactured. The system offers multiple dip tanks for solutions with various durometers. Multiple methods of form preheating and product curing are available, from convection ovens to zoned heating platens. Form spin and manipulator rotation, together with precision vertical speed and positional accuracy, offer the user multiple variations in the creation of custom dip profiles. ACC Automation, 475 Wolf Ledges Pky., Akron, OH 44309.
A coating machine automatically coats, purges, and cures customers' liquid formulations to the inside walls of their products. The machine can be customized for coating height and solution-dwell and purge-cycle times. Its manufacturer has also developed a line of catheter-processing equipment that can be specially adapted for a company's specific manufacturing needs. Automated solutions are available for catheter coating, tip forming, progressive lubrication, precision leak testing, material handling, and packaging. Production Plus Automation Equipment & Systems Inc., P.O. Box 194, Amesbury, MA 01913.
Catheter balloons are constructed from synthetic materials, including synthetic polyisoprene and polychloroprene. Produced using a special curing process, the balloons mimic some of the properties of natural rubber latex products but eliminate biocompatibility and protein concerns. The components exhibit low modulus, high elongation, low tensile set, and high resiliency. Apex Medical Technologies Inc., 10064 Mesa Ridge Ct., #202, San Diego, CA 92121.
Designed for catheter-banding applications, a cyanocrylate dispenser uses a timed air pulse to apply precise, repeatable amounts of cyanoacrylate to catheter marker bands for improvements in process control and product quality. The unit features a 0- to 15-psi regulator to accurately control air pressure at the lower settings needed to dispense thin fluids. Dispensing times as brief as 0.001 second are easily set and repeated with the microprocessor-controlled timer. EFD Inc., 977 Waterman Ave., East Providence, RI 02914-1378.
A company offers cutting services for most thermoplastic and some thermoset tubing, including those made from thin-wall and difficult materials up to 0.31 in. in diameter. With its in-house engineering staff and technicians, the firm makes close-tolerance, high-quality cuts and can provide samples for customer review. Technical guidance helps to minimize start-up costs, maintain production schedules, and stay within budget. Precision cutting machines, feeding and handling equipment, and other specialized assembly and testing machinery are also available. ASG, 2010 Seabird Way, West Palm Beach, FL 33404.
A full range of R&D and manufacturing services are offered on a contract basis. Hydromer lubricious coatings can be applied to a variety of materials and device designs. In addition, the company is skilled in manufacturing medical devices, providing assembly, packaging, sterilization, design engineering, and complete turnkey device-coating machines. Hydromer Inc., 35 Industrial Pky., Branchburg, NJ 08876-3424.
Catheter development services are offered that produce unique properties by manipulating materials, mechanical characteristics, and manufacturing parameters. Miniature tungsten cables have high strength, small diameters, and low stretch. Nitinol products demonstrate flexibility, shape memory, and kink resistance. The company can produce custom designs or work with existing specifications. Automated manufacturing services are also offered. Baird Industries, 1 Hollywood Ave., Hohokus, NJ 07423.
An automated hole-drilling system with a touch screen graphic interface provides fast setup capability and easy programming for a virtually limitless number of hole patterns. The Smart Driller TS programmable hole-drilling system offers the same versatility and accuracy as the manufacturer's other Smart Drillers and Smart Punchersfour-axis, tabletop, CNC automated drilling systems designed to drill any hole pattern at any distance, angle, and depth in single or multilumen catheter tubes. Other features include event-driven custom software, a graphical user interface, on-screen video, speed controls, large storage capacity, high-speed stepper control, microstepping axis motors, on-screen axis jog controls, and multiple I/O. Technical Innovations Inc., 20714 Hwy. 36, Brazoria, TX 77422.
A contract printing company specializes in catheters and other medical components. Services for prototypes through full production runs are available. The company provides product-tracking processes, bioburden environments, and surface modification to imprint a variety of shapes and substrates using Class VI medical-grade inks. Isoprint Inc., P.O. Box 23456, Portland, OR 97281.
Designed to replace carbide tooling, an electrofission machine straightens and cuts tubular metal parts with tight tolerances. The machine operates quickly without producing waste or changing the tubing's molecular structure. Because tooling is not used, the need for honing is reduced. Prestraightening oil is also not required in most cases. Jouhsen-Bundgens USA LLC, 2840 N.W. 2nd Ave., Bldg. 2, Boca Raton, FL 33431.
Solvent-free adhesives are USP Class VI approved and formulated to meet the unique assembly challenges associated with the latest catheter materials, such as PET, PEEK, Pebax, and polyimide. The CTH-series adhesives cure with visible or UV light, allowing cure times as much as 50% lower than those for other cure methods. The adhesives also are flexible and moisture resistant. Dymax Corp., 51 Greenwoods Rd., Torrington, CT 06790.
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