Originally Published MPMN
Originally Published MPMN July 2003
SPOTLIGHTCatheter and Stent Fabrication
Custom catheter shafts
High-performance PTFE-lined and braid-reinforced catheter shafts can be supplied tailored to meet precise requirements. Catheter constructions can include braid or coil reinforcement, multiple-durometer jackets, bonded tips, and radiopaque markers. The enhanced shafts are designed for use with guiding, angiographic, and stent-delivery catheters.
TFX Medical, 50 Plantation Dr., Jaffrey, NH 03452.
Compact necking system
A system capable of necking short or long plastic catheter tubes up to 7 ft and in various sizes also is flexible enough to neck single- or multilumen tubes and as many as three tubes simultaneously. The compact Auto Necker 830-B accurately reduces the outside or inner diameter of a length of shaft tubing, with die temperature, traverse speed, and traverse length being controlled from a front-panel keypad. The system creates smooth transitions between different diameters. It may also be used for braid embedding and lamination.
Beahm Designs, 112 Elmwood Ct., Los Gatos, CA 95032.
The wide range of catheters offered by an FDA-registered manufacturer
of disposable silicone medical devices includes Foley urine-drainage and Foley temperature sensor catheters, gastrostomy tubes, and nasogastric tubes. Custom catheters also are available, with the manufacturer's design team able to assist with product development. Besides design and production, the company provides device testing, private-label packaging, sterilization, and warehousing.
Degania Silicone Inc., 10 Nate Whipple Hwy., Cumberland, RI 02864.
Complete prototyping services
related to stents and other tubular devices are available from a firm that also offers medical device design consulting. Specialty materials worked are stainless steel, nitinol, cobalt-based superalloys, titanium, and tantalum. Full prototyping capabilities include laser machining, electropolishing and surface finishing, custom nitinol heat shaping, materials testing and characterization, and polymer coating.
Burpee Materials Technology LLC, 179 Branchport Ave., Long Branch, NJ 07740.
A line of Teflon-coated forming mandrels for manufacturing stent-delivery catheters features a 0.05 coefficient of friction for optimal release. Applied to stainless-steel or nitinol, the uniform, nonflaking coating provides a chemically inert slippery surface that tolerates operating temperatures up to 500°F. Grit-blasted wire 0.005-0.45 in. in diameter
is coated with Teflon 0.00005-0.0008 in. thick and exhibits final diameter tolerances of ±0.0001 in. The mandrels are designed for repeated use and tested to ASTM 1894.
Applied Plastics Company, Inc., 25 Endicott St., P.O. Box 128, Norwood, MA 02062.
Guidewires and stents
Specialty guidewires, guidewire tip coils, guidewire cores, catheter shaft-stiffening wires, hypotube assemblies, and pacing, defibrillation, and neurostimulation coils are available from a full-service contract manufacturer. Precision wire can be drawn down to 0.001 in. diam, and stainless-steel and nitinol wire can be ground to dimensions that small. Miniature metal tubing as small as 0.003 in. diam is produced from more than 100 metals and alloys, with many fabrication options. Custom cardiovascular and peripheral stents are made completely in-house from Type 316L stainless steel, nitinol, and cobalt chrome alloys. UTI Corp., P.O. Box 26992, Collegeville, PA 19426.
Extruded and molded components
Catheter tipping, drilling, and printing and custom configurations are among the capabilities of a full-service vertically integrated OEM manufacturer of extruded and molded medical components. The company can take a project from concept to commercialization.
In-house tooling allows rapid prototyping and short time to market. Besides subassemblies and finished catheter products, such ancillary products as peel-away introducers, Tuohy-Borst adapters, vessel dilators, guidewire introducers, monitoring lines, and caps and needles can be supplied.
Martech Medical Products, 1500 Delp Dr., Harleysville, PA 19438.
A single-source supplier of biodegradable stents and catheter delivery systems provides product development, mold design and construction, cleanroom molding, assembly, and packaging services
in addition to fabrication. Stent manufacturing capabilities include PLLA polymer processing, postmolding application of drug coatings, and integration of antirestenosis compounds into the PLLA. Insert molding, overmolding, and precision fabrication are employed in the production of catheters.
Infinity Plastics LLC, 6020 Nicolle St., Ventura, CA 93003.
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