Manufacturing Systems Today: Stent & Catheter Manufacturing

Catheter tube-bonding system
The Split Die Thermal Bonder 620B catheter manufacturing system from Beahm Designs Inc. combines two processing steps in one machine to shorten cycle times and reduce the likelihood of error. The machine offers users the ability to preshrink and bond, or fuse, two components of different diameters by applying heat and radial compression. Two heating-cooling process cycles, combined with the system's dual-die head bores, allow preshrinking and welding to be performed within a single process cycle. Bond widths can vary, and very narrow weld profiles are possible. Bonding in demanding applications, such as those calling for short balloon bonds and ultrasmooth lap and butt welds, can be executed with high precision, according to the manufacturer. The system is designed to provide high repeatability as well.
Beahm Designs Inc.
LOS GATOS, CA

Stent-crimping machine
The J-Crimp Model RJG stent-crimping machine is a full-featured radial-compression machine suitable for performing the stent attachment step in the assembly of balloon-expandable stent-delivery catheters, as well as other medical device manufacturing functions. Available from Blockwise Engineering LLC, the unit is centered on a radial-compression station with hardened-stainless-steel dies that form a cylindrical opening whose diameter can range up to 16 mm. It is suited for volume production because process parameters are stored in the memory of a programmable logic controller (PLC), and it promotes process flexibility by allowing a sequence of diameter- or force-controlled steps. A stepper motor provides power to open and close the compression station, an integrated encoder measures the diameter of the opening, and a force transducer measures the actuating force, which is proportional to the radial compression force. The system's PLC controls the compression force and may also control pressurization and evacuation of the balloon and the temperature of the compression dies.
Blockwise Engineering LLC
TEMPE, AZ

Catheter-tipping machine
A precision system for tipping medical catheters can form tips on and weld catheter components made from almost all thermoplastic materials, in addition to handling challenging tipping and bonding applications. Powered by a 1.0-kW, 450-kHz, radio-frequency generator and using high-density-carbide tipping dies, this semiautomatic machine is designed and built by Cath-Tip Inc. for rigorous industrial use. It has a keypad-entry programmable controller for heat control, part feed, part clamping, and air cooling. Two-stage heating optimizes heat control and cycle times. A stepper motor and leadscrew drive are programmed for precision part feeding and placement. In addition, quick-change tooling makes product changeovers and cleaning simple, and programmable air cooling accelerates the lowering of die temperatures to keep the tipping cycle short.
Cath-Tip Inc.
SANDY, UT

Tube- and stent-cutting system
Precision Automated Laser Systems Inc. offers the easy-to-operate PTCS-10F precision tube-cutting system for wet or dry cutting of tubular metal components ranging in diameter from 0.010 to more than 1 in. Featuring fiber laser sources and automated material indexing, the system can cut stents and catheters. It is suited for cutting nitinol stents, allowing the use of oxygen or argon assist gases when cutting wet or dry. The compact unit has application in both large production facilities and small R&D labs and can be used to advantage by job shops and providers of part-processing services.
Precision Automated Laser Systems Inc.
SAN CLEMENTE, CA

Balloon catheter inspection system
The Auto-i 360 balloon inspection system is intended to enhance catheter quality control by making it easier to find, identify, and classify such defects as gel spots, "fish eyes," and foreign particles. Manufactured by Interface Catheter Solutions, the system performs both visual inspection and dimensional measurement of medical balloons in a single operation, classifying and sizing defects and issuing a pass-fail determination with detailed analysis and data reporting. It uses a high-speed camera and telecentric measuring lens to measure all dimensional aspects of the balloon and detect even very small flaws. Its pressure capability to 13 atm makes it compatible with compressed air or nitrogen. Gauge R&R analyses have found the system to be an accurate, consistent, and reliable tool for balloon inspection that can significantly reduce inspector-to-inspector variability.
Interface Catheter Solutions
LAGUNA NIGUEL, CA