GE Helps ZEVEX’s EnteraLite® Infinity™ Feeding Pump Give Tube-Fed Patients the Freedom to be Active

ZEVEX International, Inc., an innovative company based in Salt Lake City, Utah, entered the enteral nutrition delivery market in 1996 and currently distributes a complete line of products for use in patients’ homes, hospitals, and nursing homes. Enteral feeding delivers liquid nutrition directly into the gastrointestinal tract. It is prescribed for a wide range of short-term and chronic conditions such as stroke (swallowing difficulty), cancer (insufficient calories), food absorption, and digestion disorders. Observing the trend toward smaller, lighter, and more portable medical devices, ZEVEX decided to create a new product that would apply miniaturization technology to enteral feeding systems to benefit patients.

The Challenge: Designing an Enteral Feeding Pump Offering Mobility, Accuracy, and Ease of Use.

Existing enteral feeding systems restricted patient mobility: some had to be attached to IV poles, while others, though movable, depended on a gravity-based pump for sensing flow and blockages. Such devices could only operate in an upright position. The ZEVEX team wanted to take a major step forward and allow patients – especially children – to enjoy the freedom and health benefits of physical activity while receiving feedings. The company envisioned a device that would perform with precision in any orientation, while incorporating stringent safety features and easy operation to allow family members to be comfortable using it.

“Our goal was to create a next-generation design that would improve quality of life for tube-fed patients,” said Charity Williams, Director of Marketing, ZEVEX. “In particular, we wanted to let kids have the freedom to play with friends and enjoy school activities and family outings while receiving their feedings from a discreet, portable device. But to make this concept a reality, we needed fresh approaches and innovative materials. One critical area was tubing.”

The system that ZEVEX designed featured a peristaltic pump whose squeezing action pushed liquid through tubing at a programmed flow rate; optical sensing systems to monitor for occlusions and air-in-line; and a disposable tubing/frame component that snapped into the device. However, it soon became apparent that traditional smooth, extruded tubing could not meet the requirements of this new design. “We needed a new approach to deliver a complex part with precise dimensions to integrate with the pumping mechanism and sensors, as well as high performance to ensure accuracy,” said Phil Eggers, Vice President of Research and Development, ZEVEX.

The Solution: GE – Silicones’ LIM* 6050-D2 LSR for Liquid Injection Molding

ZEVEX turned to GE – Silicones for a solution to this tubing challenge. To achieve the part complexity and precision that ZEVEX required, the company selected GE - Silicones’ LIM 6050-D2 liquid silicone rubber for injection molding. This material offers excellent tear strength that facilitates the fabrication of a complex part, very high tensile strength to prevent distortion arising from the peristaltic pumping action, and very tight control over durometer and modulus to assure precise pump delivery of nutritional fluid from every batch of molded tubing. Working closely with ZEVEX, GE - Silicones helped to optimize material and processing interactions using Six-Sigma tools.

The resulting 6.5-inch-long part incorporates precisely molded flanges and posts that integrate tightly with the pump and sensing system to ensure accurate fluid delivery, pressure detection, and free-flow protection. Its dimensional precision is also critical to proper placement and seating of the disposable tubing-cassette sub-assembly into the EnteraLite Infinity pump by the patient or family member. “The tubing design helps make it impossible to load this part incorrectly,” said Chris Steinman, Disposables Products Engineering Manager, ZEVEX. “This is very important to ensure correct operation and facilitate replacement, which must be done every 24 hours.”

GE – Silicones’ LIM 6050-D2 LSR is a highly engineered liquid silicone elastomer that offers excellent physical properties essential to continuous dynamic pumping performance. Further, the material is biocompatible1 and compliant with USP Class VI. It is also an excellent candidate for mechanical parts such as connector inserts, seals, and flexible mounts.

LIM 6050-D2 silicone offered a two-component system that can be accurately dispensed using conventional liquid injection molding equipment. It is designed to offer fast cure at typical injection molding temperatures, resulting in very high productivity, flashless parts, and negligible scrap.

The Benefits: Award-Winning Design Achieves Vision of “Active Freedom” for Patients

The ZEVEX EnteraLite Infinity device, which won a Silver Medical Design Excellence Award at the 2005 Medical Design and Manufacturing Conference and Exposition, utilizes the precision and strength of tubing molded from GE –Silicones’ LIM liquid silicone rubber to help deliver consistent performance, safety, and mobility. In fact, the GE material is instrumental in maintaining a volumetric flow rate level accurate to within +/- 5 percent. This high level of accuracy helps facilitate that the patient receives the prescribed amount of nutrition in a controlled manner.

The robust pump design along with the injection-molded LIM 6050-D2 LSR part enable great accuracy control, even when the pump is in non-stationary positions. Children and adults have the freedom to enjoy normal activities by simply wearing a small backpack holding the device and nutrition-delivery set.

“We’re proud that ZEVEX has selected a GE – Silicones product to help meet the demanding needs of this smallest, most portable enteral feeding system available today,” said Eric Luftig, Healthcare Marketing Manager for GE – Silicones. “GE’s innovative materials are making a difference in healthcare where it’s most critical – in the quality of life for patients from infants to the elderly.”

Future Plans

The design flexibility of GE’s LIM 6050-D2 LSR offers ZEVEX the opportunity to grow its business by applying the Infinity technology to other fluid management systems such as infusion pumps and hemodialysis machines.

Details at:

http://www.zevex.com

Reader enquiries

GE Bayer Silicones GmbH & Co. KG
Building V7
51368 LEVERKUSEN
Germany

Robert Scheib
robert.scheib@ge.com

Tel: +49 214 306 71 37
Fax: +49 214 306 71 26
Germany
+49 214 306 71 37
robert.scheib@​ge.com
www.ge.com

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Notes for editors

About GE - Advanced Materials

The Advanced Materials business of General Electric Company is part of the Industrial business group and is headquartered in Wilton, Conn. Comprised of Silicones and Quartz, GE - Advanced Materials is a global leader in providing a range of high-technology materials solutions. The GE - Advanced Materials, Silicones’ portfolio includes silicone-based products and technology platforms, silanes, sealants and adhesives. The Quartz portfolio includes high-purity fused quartz and ceramics materials. These materials solutions are used as catalysts for innovation in hundreds of consumer and industrial applications ranging from car engines to biomedical devices to integrated circuits. Markets served include aerospace, agriculture, appliances, automotive, construction, electronics, furniture and furnishings, healthcare, home care, industrial, lighting, packaging, personal care, plastics, semiconductor, telecommunications, tire, transportation, and water purification. As a Worldwide Partner of the Olympic Games, GE is the exclusive provider of a wide range of innovative products and services that are integral to a successful Games. Experience more at www.ge.com/advancedmaterials.

* EnteraLite, Infinity, and ZEVEX are trademarks of ZEVEX International, Inc.

* LIM is a trademark of General Electric Company.

1 Biocompatibility: A representative lot of material tested either by ISO 10993 or USP VI protocol.