TPE tubing for peristaltic-pump applications
Used in peristaltic-pump applications, tubing made from thermoplastic elastomer (TPE) resins has passed usable-life testing of more than 500 hours, according to its manufacturer. PVC-, phthalate-, DEHP-, latex-, and silicone-free, the TPE material used to fabricate Flexelene 135C tubing is generally nonpyrogenic, nonhemolytic, and low protein binding, making it suitable for medical device applications. The TPE grades used to produce this tubing are flexible, kink resistant, and elastic. Exhibiting low outgassing levels and oxygen permeability, they can also withstand autoclave temperatures of 135°C and can undergo EtO or gamma sterilization. In addition, they comply with BSE/TSE non-animal-derivative, USP Class VI, ISO 10993-4, and ISO 10993-5 requirements. Produced in a cleanroom, the tubing is available with standard nominal dimensions and can be custom manufactured to meet specific pump requirements.
EJ BioMed/Eldon James Corp.
Tubular parts for medical device applications
Specializing in thin walls, tight tolerances, tube bending, specialty tube fabrication, and end-forming, a manufacturer offers tubing products and tube-processing services for the medical device industry. Used in a variety of applications, especially products for minimally invasive procedures, the tubing is available in configurations and assemblies that range from simple to intricate. The manufacturer’s fabrication processes include tube cutting using electrochemical machining, four-slide, CNC Swiss lathe, score, and saw operations. Its tube forming operations use rotary and single-station press, four-slide, swaging, bending, punching, die-reducing, and custom processes. In addition, the company machines tubes using CNC Swiss lathe, electrochemical grinding, and driller equipment and performs tube finishing using bead blasting, bright dipping, tumbling, and passivation techniques. Working with a variety of materials, the firm offers an array of tube shapes in sizes and lengths to suit most medical device manufacturing needs.
Judson A. Smith Co.
Proximally reinforced catheter tubing
A line of custom catheter tubing features wire reinforcements embedded within the wall at the proximal end of the catheter and no reinforcement on the distal end. Available in small diameters for neurovascular applications and in diameters up to 1 in. for gastrointestinal and other natural-orifice devices, proximally reinforced catheter shaft tubing is fabricated using integrated extrusion, wire-wrapping, and welding technologies. These techniques reduce costs and improve quality compared with traditional hand-layup methods, according to the manufacturer. While single-material catheter tubing lacks flexibility at the distal end and sometimes lacks the necessary rigidity at the proximal end, catheter tubing with embedded stainless-steel wire reinforcement on the proximal end can improve pushability, torque transmission, and kink resistance. Allowing the distal end of the same tube to remain unreinforced provides flexibility, optical clarity, and x-ray transparency. Reinforcement options include braided wire for torque transmission and coiled wire for kink resistance.
PolyMedex Discovery Group
Laser-machined catheter tubing
A company providing catheter tubing employs laser ablation. This machining method vaporizes material by matching the tube material’s absorptive properties to the proper laser wavelength and applying this wavelength to the material with the correct energy density and duration. Unlike mechanical machining, this technique does not rely on heat to melt or burn away material, producing clean, precisely machined features with no heat-affected zones, according to the manufacturer. This method also does not cause the flaws that are common to standard machining. Laser ablation is used to produce tubing with such intricate features as holes, slots, recessed areas, and tapers, relying on a controlled manufacturing process to transform tube extrusions into conduits for electrical transmission, fluid delivery, or aspiration. Because laser ablation uses a wavelength that interacts only with the catheter tube’s polymer material, it does not affect the interior metal portion.
Silicone extrusion capabilities
A manufacturer has expanded its medical silicone tube-extrusion capabilities to include systems that perform in-line close-tolerance cutting of silicone tubing directly from the extrusion machine. New capabilities also include in-line spooling and cut-to-length tube forming from spools. Providing medical device OEMs with design options for achieving precision and repeatability, the systems can extrude single-lumen, multilumen, solid-rope, and rod silicone tubing with inner and outer diameters ranging in size from 0.020 to 1 in. Precise dimensional control throughout a part run is ensured using closed-loop feedback control from a Zumbach laser micrometer. Also available are processes for overmolding materials onto the silicone tube and bonding silicone tubular parts to plastic and metal parts using medical-grade adhesives. Operating an ISO 9001:2000–certified facility, the company also offers lot traceability; pad-printing of identification marks on silicone tubing for positioning purposes; and a variety of optional tubing color characteristics, including clear, translucent, opaque, and colored versions.
Thermoset polyimide tubing
To meet the demand for consistent, close-tolerance control over tubing inner diameters, a manufacturer offers thin-walled thermoset polyimide tubing for medical applications. The tubing is suitable for a range of applications, including catheters, urological retrieval devices, intravascular drug-delivery systems, balloon angioplasty, and stent-delivery systems. Thermoset polyimide offers chemical resistance, dielectric strength, and thermal endurance, enabling the fabrication of tubing that is flexible, lightweight, nonflammable, dimensionally stable, biocompatible, radiation resistant, and transparent. In addition, the tubing can be braided for reinforcement, coextruded with selective outer and inner layers, or impregnated with PTFE. Produced in an ISO 9001:2000–certified facility, the tubing is available with inner diameters ranging in size from 0.006 to 0.080 in. and wall thickness ranging in size from 0.0005 to 0.010 in.
Radcliff Tubing Technologies
Peroxide-cured silicone tubing
A manufacturer of tubing and related products offers peroxide-cured silicone tubing, which has greater resilience and durability than platinum-cured silicone tubing, according to its manufacturer. Available with 50 Shore A hardness, the tubing is offered in sizes ranging from 0.012 in. ID × 0.025 in. OD and 0.750 in. ID × 1.000 in. OD. Operating an ISO 9001:2000– and ISO 14001:2004–registered facility, the company also provides a range of other tubing options, including products made from PVC, DEHP-free PVC, C-Flex, Tygon, PTFE, and polyethylene. These tubes are available in single-lumen, multilayer, and coiled configurations and can be customized with a variety of diameters, durometers, lengths, colors, and lumens. They are also supplied with a range of striping, printing, and packaging options. To complement its tubing, the firm also stocks preassembled extension lines with different types of connectors, tubing holders, luers, valves, clips, clamps, and barbed connectors.
Published in MPMN, November/December, Volume 26, No. 9
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