Laser-marked polymer tubing
Avicenna Technology can provide markings such as product and serial numbers, bar codes, Data Matrix codes, and branded logos on polymer tubing employed in long-term-implantable cardiac and neuromodulation leads. The technology produces a photochemical change in color so that a mark is embedded in the tube wall with no disruption of the tube’s surface or its bulk polymeric properties. Using low-energy near-ultraviolet laser technology, the company is able to inscribe multiple lines of text on very small leads and catheter tubes, including those featuring difficult-to-print surfaces. Furthermore, the biocompatible markings are indelible and do not smear, leach, or fade. The service provider can also give tubular components of temporarily implanted catheters and device-delivery systems depth insertion and product-orientation markings, or regulatory symbols. Additional company services include product design assistance, product qualifications, and inventory management.
Autoclavable TPE tubing
Flexelene 135C thermoplastic elastomer (TPE) tubing from Eldon James Corp. is autoclavable at temperatures up to 135°C. Able to satisfy industry expectations for high-grade medical tubing, the TPE product is durable enough for use in peristaltic pumps, is heat-sealable and thermally weldable, exhibits low gas permeability, and withstands EtO sterilization and gamma sterilization at a radiation level of 45 kGy. The raw material is free of animal derivatives, is nonpyrogenic, features low protein binding, and contains no halogens or phthalates. In addition, it meets USP Class VI requirements and the cytotoxicity and hemolysis requirements of ISO 10993-5 and ISO 10993-4, respectively.
Eldon James Corp.
Custom extrusion capabilities
Extensive tubing extrusion capabilities enable contract manufacturer Forefront Medical Technology to provide a variety of specialty components and finished medical disposable devices. Components are extruded from silicone, polyurethane, medical-grade PVC, and other specialty materials formulated with customized physical properties, such as durometer, color, and elongation. Specialty applications include extrusions wound with stainless steel or nitinol wire to produce reinforced, nonkinking tubing in lengths up to 75 cm and outside diameters of 5 to 20 mm. The company’s full portfolio of capabilities comprises product design and development, rapid prototyping, in-house tool construction, injection molding, extrusion, Class 10,000 cleanroom assembly, testing, packaging, sterilization, and global logistics.
Forefront Medical Technology
Gimac offers integrated extrusion systems for catheter manufacturers. New systems emphasize material flexibility and performance, precision, flexibility, streamlined design, and ease of use. The recently introduced machinery features capabilities in the areas of elongation range and consistency that are particularly suited for FEP, polyamide 12 (PA12), and PEBA materials. It also handles a range of intermittent durometer combinations and vacuum-sizing for FEP, PEEK, polyimide, and amorphous PA12. Elongation and mechanical properties can be controlled and optimized via new control logic. The manufacturer is also developing novel polymer blends to improve the potential of totally intermittent extrusion, accommodating variable durometers up to 40 Shore D.
CASTRONNO (VA), ITALY
Grayline Inc., a manufacturer of flexible polymeric tubing, offers the thermoplastic elastomer MD75-TPE for medical devices that require tubing made from a non-PVC material. This TPE is a PVC alternative that displays a high level of clarity and provides kink resistance, clamp resilience, and performance characteristics that are similar to those of PVC, according to its manufacturer. Its formulation does not contain added plasticizers, including DEHP or any other phthalate, and is able to withstand sterilization by means of gamma irradiation, EtO, and autoclaving. Typical medical tubing applications for this material include negative-pressure wound drains; insufflation tubing; suction, extension, oxygen, and drain lines; and protective coverings. Application engineers are available to provide customers with product development support.
Platinum-cured silicone tubing
Silcon Med-X medical-grade silicone tubing is platinum-cured to achieve a high degree of purity that is suitable for medical and biomedical fluid-transfer applications. Manufactured by NewAge Industries, the tubing contains few extractables and no plasticizers. The elastomer used in its manufacture meets USP Class VI requirements, and the tubing is produced in a controlled environment. The tubing is soft, pliable, resistant to bacterial growth, and nonreactive to body tissues and fluids, although it is not recommended for implantation or in-body use. It is stocked in 17 sizes ranging from 0.030 to 0.625 in. ID and is supplied in individual heat-sealed polybags. Custom sizes, durometers, and colors are also available. The tubing can be redeployed after sterilization using autoclaving or gamma irradiation.
NewAge Industries Inc.
Ultra-low-pressure air regulators
MicroAir air-pressure regulators and controllers are available from On Line Controls Inc. in ultra-low-pressure versions. Standard sizes range from 0–2 in.H2O to 0–5 in.H2O, while specialty sizes are as low as 0–0.25 in.H2O. The high-precision constant-pressure devices help maintain tight tolerances on tube dimensions even when flow rates vary. To support the extrusion of multilumen, bump, and taper tubing, the supplier offers multichannel units and regulators that provide instantaneous switching between two pressures. The product line includes a manual-control pressure regulator and a regulator that accepts contact closures and can be supplied with remote control. The line also includes a high-speed programmable controller for bump and taper tubing with 0- to 10-V input. Featuring a contact-closure option, this model can be configured as an all-in-one unit.
On Line Controls Inc.