BY MATT VINCENT
Manufacturers of connectors and assemblies continue down the path of innovation to serve the medical industry’s increasingly complex and demanding electronic needs. Recently, several manufacturers hit the market with new products and technologies.
In October, Cicoli Corp. (www.cicoli.com), a manufacturer of high performance silicone cables and assemblies, introduced a line of miniature silicone cables for medical and other compact electronics. When announcing the product, the company noted that sophisticated medical devices, such as infusion pumps, auto-injection systems, and advanced surgical instruments, offer a unique set of challenges to the manufacturer. To be re-usable, the device must withstand the rigors of autoclaving, alcohol washes, chlorine bleach baths, and other sterilization procedures. Where bodily contact is a factor, hypoallergenic materials must be used, and all wires or probes must be soft to the touch.
Cicoil said its silicone cabling is ideal for use in the medical industry because it is one of the few technologies that meet all such requirements. The miniature cables are made of medical-grade silicone, and compatible with most medical connectors. The cable assemblies are designed to withstand temperature extremes and chemical sterilization without becoming brittle or degrading.
 A proprietary extrusion process from Cicoil Corp. allows multiple wires, fiber optics, and fluid or pneumatic tubing to be placed in a single flat cable. |
Cicoil says the silicone used in its cables is extremely flexible and soft to the touch, allowing the cables to be used in direct contact with the human body. In addition, the silicone cables can be provided in FDA-approved versions for human-implant applications. Hearing-aid miniaturization is a typical example of health and medical products benefiting from silicone electronic cable technology.
The company says its proprietary extrusion process allows multiple wires, fiber optics, and fluid or pneumatic tubing to be placed in a single flat cable, precisely controlling the wire/conduit spacing, insulation thickness, and overall cable shape. The soft silicone encapsulation is also designed to provide extreme flexibility for motion applications.
Cicoil reports that its cables have been tested for tens of millions of cycles to ensure reliable performance and long life. Cables are available in continuous lengths (“cable-only”), or as assemblies with connectors.
Also in October, W.L. Gore & Associates introduced its Microminiature Round Cable (www.gore.com/medicalcable). Gore claims the cable provides one of the smallest, most durable medical cable solutions for such applications as electrophysiology products and small diameter flexible endoscopes.
Through the use of a proprietary high-strength, toughened fluoropolymer (HSTF) and low dielectric constant expanded PTFE (ePTFE) material, Gore says the micro-miniature cable maintains its performance through device flexure, abrasion during routing, or tracking and sterilization. The HSTF material is an advanced biocompatible dielectric designed to produce superior mechanical and electrical properties. Mechanical property benefits include increased scrape abrasion resistance, cut-through resistance, and improved pinhole-free performance in ultra-thin profiles.
Meanwhile, electronics manufacturing services provider FlexOne (www.flexone.com) has announced that it has achieved ISO 13485:2003 Medical Device Quality certification.
“Achieving the rigorous requirements that ISO 13485 certification entails acknowledges our long-standing commitment to high-reliability medical device manufacturing,” notes FlexOne CEO Shay Ahmed. “In conjunction with our existing one-stop-shop medical device manufacturing services, FlexOne offers medical OEMs a responsive, full-capability manufacturing partner that simplifies all phases of product development, while ensuring the highest-quality possible.”
FlexOne asserts that its medical “one-stop-shop” model provides medical device manufacturers with one point of contact to handle all aspects of design, parts procurement, prototyping, manufacturing, and regulatory and plastics requirements for their devices.
