Equipment Update

EQUIPMENT NEWS

Fluid-dispensing workstation enhances assembly process control

A dispenser of adhesives and other fluids that are used in catheter assembly has been engineered to maximize yields, contain costs, and provide good process control. Available from EFD International Inc. (Dunstable, Beds, UK; www.efdinc.com), the Ultimus dispenser accurately and consistently deposits fluid materials in drops as small as 0.10 mm in diameter. Another intended benefit of the system is that training in its use generally requires little time.

The vertical design of the dispensing workstation results in a footprint said to be 60% smaller than that occupied by standard dispensers of the type. The system additionally features slotted side panels for mounting accessories. It can be fitted with options such as a flexible task light, a 1.7 × magnifier, a flexible syringe-barrel holder, and an ergonomically designed barrel grip with a touch-sensor finger switch and a spotlight that uses a light-emitting diode.

Simultaneous digital displays of all parameters make possible greater process control than standard analogue gauges allow, while an internal pressure reservoir and rapid-response solenoid optimize deposit control and minimize cycle time. Automatic voltage regulation from 85 to 265 V, automatic standard-to-metric conversion of dispensing parameters, and security lockout are other features. The instrument can be set to display in English, German, French, Spanish, Italian, Chinese, Korean, or Japanese.

Instrument tests each lumen of multilumen catheters for leaks

Offered by the Air Leak Testing subsidiary of Vacuum Instrument Corp. (Ronkonkoma, NY, USA; www.vicleakdetection.com), a multi­lumen-catheter test instrument enables catheter man­ufacturers to handle the demanding quality control requirements such complex medical device components impose. The MLC tester is up to the task of thoroughly checking catheters that measure 3 to 4 mm in diameter and contain as many as seven fluid- or signal-carrying lumens. The testing process involves checking each tubing lumen individually for leakage and investigating whether any passageway is blocked or partially occluded.

The multilumen test system employs dry air or any gas to perform three tests automatically on each lumen. It checks for external leakage and interluminal leakage and conducts a flow test to determine whether an occlusion exists. Results of each test are displayed on a front-panel digital readout and can be permanently recorded via an optional printer. The mass-flow test method used ensures speed and accuracy. It generates a direct readout of leakage expressed in cubic centimetres per minute and of flow rates in litres per minute, or, optionally, in other units.

To operate the unit, the user places the catheter in a built-in fixture, attaches the fittings, and presses the start button. Leak and flow testing of a three-lumen catheter typically takes 10 seconds.

Plasma treatment system facilitates overmoulding and bonding

Suited for use with materials such as PTFE variants and exotic metals such as nitinol, a plasma treatment system cleans and modifies the surfaces of catheter parts, enabling them to be overmoulded and bonded. Plasma Etch Inc. (Carson City, NV, USA; www.plasmaetch.com) has in fact recently upgraded its PE-100 benchtop plasma system by adding an accurate mass-flow meter as well as a pre­cision needle valve in the gas train. The system is designed to support positive and leak-free adhesion in component joining.

The latest version of the plasma treatment system comes standard with one mass-flow meter but may be ordered with additional meters as needed. The precision instrument is also supplied with an oxygen-service vacuum pump. In addition, it may be specified to include an optional oil-free scroll pump and multiple mass-flow controllers.

PC-controlled processor applies uniform heat for catheter lamination

Thermal shrinking systems for catheter tube processing offered by a specialty company can apply heat to a variety of delivery system tubing, including stent delivery systems, guiding catheters, diagnostic catheters, urinary catheters, and other braided or coiled catheter products. Machine Solutions Inc. (Flagstaff, AZ, USA; www.machinesolutions.com) has designed the VS1100 vertical shrinker for catheter lamination applications. The processor is controlled from a personal computer.

The unit’s Microswirl 360° thermal nozzle provides uniform heating. With this nozzle design, the incidence of hot or cold spots developing during the shrinking process is likely to be less than with flat- or C-nozzle technologies. The vertical shrinker features four processing stations, programmable and accurate speed settings for each item being processed, and multiple programmable heat zones that are accurate to better than 1 mm. Profiles can be saved and recalled as needed, facilitating setup and providing process repeatability.





Polarimeter makes inspection of strain patterns fast and easy

An inspection system consists of a very precise laboratory-quality polarimeter equipped with a colour charge-coupled-device video camera with 10× zoom magnification and a high-resolution 17-in. colour liquid-crystal display monitor. The Series PS-100 macrovideo polarimeter system available from Strainoptics Inc. (North Wales, PA, USA; www.strainoptics.com) facilitates inspection of strain patterns in clear and translucent plastic components. The unit uses photoelastic techniques to perform accurate measurement of birefringence and to detect unacceptable gradients of stress or strain in light-transmitting materials. It is compatible with ASTM standard test method D4093.

The system can reveal often visually undetectable defects that can result in cracking, warpage, reduced material strength, or other problems that may lead to field failures, patient injury, and product liability litigation. Inspection applications for this polarimeter include medical-grade catheter tubing, implants, prostheses, various other biomedical devices, optical lenses, and pharmaceutical packaging.

The system is alternatively available without the video camera and monitor. Also, custom configur­ations can be provided to meet special application requirements.

X-ray inspection system magnifies objects up to 25 times

Proprietary real-time x-ray microscope technology is offered for use in the development and quality assurance of stents, catheters, vascular filters, vascular closure devices, and heart valves. The x-ray detector technology from Glenbrook Technologies Inc. (Randolph, NJ, USA; www.glenbrooktech.com) makes available detailed fluoroscopic images magnified up to 25 times.

The firm has developed the RoteX inspection system for the real-time study of the blood-clot trapping efficiency of vena cava filters. Supporting 180% of movement, its x-ray camera can rotate around a vascular model and digitally record fluoroscopic videos of dynamic events. The firm’s x-ray microscope technology can perceive details as small as 0.001 mm. Advanced system sensitivity allows such low-density structures as silicones, polymers, and blood vessel walls to be imaged. Digital videos of the fluoroscopic images can be recorded on a computer.

The comany’s JewelBox x-ray inspection systems, based on the same tech­nology, are suitable for studying stent failure after fatigue testing. They can video-record an x-ray movie of the deployment and actuation of the stent. Available in two configurations, the JewelBox technology can be configured for a range of applications and materials including silicone rubber, polymers, and collagen, as well as stainless steel, platinum, and titanium.

Microcoil winder unit carries CE certification

Capable of producing a microcoil smaller than a human hair, a continuous coil winder winds one or two filaments around an axially moving mandrel. The microcoil can then be processed for use in medical devices such as catheters. Having obtained CE certification, the machine developed by Engineering By Design (San Jose, CA, USA; www.ebdesign.com) thus may be used almost anywhere in the world.

Unlike traditional continuous winders that control tension with sometimes inconsistent open-loop friction and spring devices, this machine's winding technology features control of the closed-loop tensioning by means of an embedded processor. Wireless Ethernet communications capability is provided for remote monitoring and to facilitate software updates. The machine offers accuracy of 0.1 g at tensions below 1 g. Also, a vision system controls the wind angle with an accuracy of 0.2°. Microcoils can be wound continuously with high precision.