Medical Device Link.

Originally Published EMDM March/April 2003

EQUIPMENT NEWS

Manufacturing equipment handles tube-processing requirements

A complete range of machines for tubing processing is available from a company specializing in medical device production equipment. Among the products offered by Tecnoideal S.r.l. (Mirandola, MO, Italy) are programmable cutting machines for tubing in reels or on an extrusion line. These cut PVC, silicone, and other tubing for biomedical applications precisely and accurately. Tubing expanders and coiling and banding machines for tubing sets also are supplied.

Solvent and UV-activated-adhesive dispensers can dispense to the outer or inner surface of tubing and other components. Other tube-processing equipment in the specialty range includes machines that perform not only routine leak and obstruction testing in production, but also validation and destructive testing in R&D and quality assurance settings. Semiautomated assembly workstations round out the manufacturer’s standard equipment line.

In addition, the manufacturer is able to design and produce completely automatic, hands-off custom systems for the assembly and testing of medical tubing sets.

Automated catheter-hole driller features intelligent control

A versatile programmable hole-drilling system is designed to drill any hole pattern, at any distance, angle, or depth, in single- or multilumen catheter tubes. The Smart Driller TS offers the same accuracy as the other four-axis tabletop CNC drilling systems designed and built by Technical Innovations Inc. (Brazoria, TX, USA). The automated system has a touch screen graphical interface to facilitate setup and programming, and features generous storage capacity. Other control and operating elements include event-driven custom software, on-screen video, speed controls, microstepping axis motors, on-screen axis-jog controls, and multiple inputs and outputs.

The drilling system also is equipped with the ability to detect hole plugs. It counts and collects the plugs generated during catheter-hole making so as to prevent the by-products from interfering with system function.

The full line of drills and punches for placing holes in medical tubing that this manufacturer offers range from simple machines to automated electrical hole-drilling and pneumatic punching systems.

Equipment automates manufacture of balloon catheters and stents

A range of advanced processing equipment for balloon catheters and stents is based on segmental compression technology. Developed by a founder of Machine Solutions Inc. (Flagstaff, AZ, USA), the easy-to-use technology involves imparting an even radial compression force to a product placed in a process chamber. It is incorporated in equipment for stent crimping, catheter balloon pleating and folding, and marker band swaging, and is designed to improve yields, minimize cycle times through the elimination of process steps, and reduce the profiles of crimped stents and balloons.

The T2 line of stent-crimping equipment is controlled by PLC and has automation features that maximize operator efficiency and streamline product handling. In comparison with conventional crimping methods, the systems eliminate manual prereduction crimp steps, improve stent retention, and provide protection of stent edges.

Also available is balloon form-fold-set equipment that can replace labour-intensive and unreliable pleating and folding of angioplasty and stent-deployment balloon catheters with an automated process. Proprietary pleating technology ensures balloon profile consistency and repeatability, as well as consistency in balloon unfolding during stent deployment.

All equipment is built to customer specifications. The needs of start-up companies to multinational giants can be met.

Small coextruder produces miniature three-layer tubes

A coextrusion line less than 3 m long is available for the production of small, calibrated tubes measuring 0.4 to 4 mm OD and made of rigid or soft materials. Gimac (Castronno, VA, Italy) has designed the system for medical and pharmaceutical applications. Tubing can have as many as three layers and radiopaque striping. The line can be set for production output of 0.1–4.5 kg/hr. The machines composing it can be delivered singly or with a table support.

Chief components of the coextrusion line are three microextruders equipped with a 1.1-kW ac motor with encoder feedback and featuring a maximum screw speed of 100 rpm, along with an extrusion head for producing tubes of 1, 2, or 3 layers. Other elements include a vacuum calibrator with cooling unit and water recirculation tank, a laser gauge for diameter control, a haul-off with a maximum speed of 84 m/min, and a control cabinet. The line features a programmable logic controller and is operated via a personal computer with touch screen. Both of these controls are by Allen Bradley, and the extruders and haul-off are controlled by an Allen Bradley vectorial inverter.

Ultrasonic welders facilitate catheter assembly

The assembly of catheter components—specifically, joining valves to catheter tubes and cutting holes in the tubes—is an application tailor-made for ultrasonic welding technology. The Rinco Dynamic series of ultrasonic welders have the force-profiling and computer-interfacing capability necessary to satisfy high medical industry standards in this area of manufacturing. Supplied by Forward Technology Industries (Luton, UK), these machines can measure the level of energy absorbed by the welded assembly during the process of attaching plastic valves, thus ensuring application of the correct level and achievement of consistently high-quality and reliable welded assemblies. They also accommodate data logging and printing of results.

Cutting holes in catheter tubing requires special tooling as well as the process control afforded by this line of welders. These also are provided by the manufacturer. Tooling that can cut holes with radiused edges makes possible a smooth outer surface of the tube. The ultrasonic welding systems provide the high degree of rigidity necessary for this function to be performed flawlessly.

Catheter-manufacturing system forms large profiles

An established line of catheter-manufacturing systems now includes a new higher-power model that is able to perform multiple part tipping and to form large-profile and long-neck-down catheters with speed and accuracy. The PIRF III system developed by Sebra (Tucson, AZ, USA) also features temperature control and mould design functionality, pneumatics or stepper motors with force-sensing capabilities, temperature monitoring with out-of-range alarms, a precision digital air-regulator assembly, and quick-release mould fixturing. Programming the processing parameters from the machine’s front panel is easily accomplished.

This is the second version of the PIRF system designed to handle special projects. The PIRF II system is specifically designed for tipping and welding small-profile catheters. That system provides precise heat placement and temperature control in order to optimize tip quality and weld strength. A video demonstration of these catheter-manufacturing systems is available at the company Web site.

Ultrasonic welding machines offer interactive process control

Both standard and custom-built ultrasonic welding machines for processing thermoplastic components and nonwoven materials are available from a manufacturer supplying the European and North American markets. With a high level of process reproducibility being its goal, Hermann Ultraschalltechnik GmbH (Karlsbad, Germany) developed the HS Dialog series of ultrasonic welders that offer interactive control of welding parameters from a menu-driven colour touch screen and the ability to print out welding parameters, statistical data, and graphs.

Every aspect of the process is checked, from the setting of trigger and weld forces and weld depth, to process results, which are compared with reference data. The most important parameters are displayed graphically for analysis by the operator and possible modification for process improvement. Once parametric limits are set, the welding system automatically rejects workpieces that are out of specification. Parameters for a variety of applications can be stored in memory. Operational precision is ensured by a proportional valve that controls weld force and by a linear encoder that controls positioning within 0.1 mm. Force can be changed during the welding process to accommodate the requirements of amorphous and crystalline materials.

All equipment produced by the ISO 9001–certified manufacturer is CE marked. Besides standard machines with up to 5000 W of power and versions customized to meet customer needs, the company offers patented systems that can weld and cut nonwovens continuously.

Tube cutter takes on plastic, rubber, and elastomers

A versatile tube-cutting machine cuts plastic, rubber, and elastomeric tubing with diameters as large as 2 in. in any amount longer than 3 in. A single unit of the Model 125B-1 medical tube cutter from Lakeview Equipment Inc. (Northbrook, IL, USA) can be used to cut tubing of different diameters and to make cuts of different lengths by means of interchangeable bushing sets sized to the customer’s specifications. Two tubes of any diameter up to 3¼4 in. may be cut simultaneously as long as material composition, material hardness, and wall thickness permit. The hand-fed 7-lb, 6 ¥ 15-in. machine is intended for limited production runs.

The tube cutter is pneumatically operated at up to 100 psi via finger switch or foot pedal. Blade ram speed is adjustable. A counter, additional bushing sets, and extra blades are available from the manufacturer, who also offers complimentary evaluation of tube-cutting requirements. The blade and bushing sets can be replaced quickly and easily.

Automatic taping machine secures medical tubing

Medical device manufacturers can use a specialized machine to automatically tape tubing and catheter sets before placing them in packages. The Tayp-R, produced by S-Y-M Products Company, LLC (Stamford, CT, USA), not only dispenses but also seals the paper cohesive tape around the coil. It is available to handle tape widths of 12.7, 19, and 25.4 mm. The all-electric machine operates on standard line voltage and does not require air.

Easier, faster, and safer than manual taping methods, the system requires the operator to do nothing more than insert a bundle of tubing into the machine’s jaws and then withdraw the finished product. The tape is automatically fed and cut in a continuous operation. The taping machine can be integrated with other tubing-processing equipment to create a cost-efficient single packaging operation of coiling and taping.


Copyright ©2003 European Medical Device Manufacturer