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Prent Blister Package Adds Function to Ethicon Endo-Surgery Biopsy Device

By David Vaczek

Prent developed a multitasking two-piece package for carrying and dispensing tubing used with Ethicon Endo-Surgery’s EES Mammotome biopsy system.

Ethicon Endo-Surgery (EES; Cincinnati) develops and markets advanced medical devices for minimally invasive and open surgical procedures. The EES Mammotome biopsy system is a minimally invasive device to help doctors diagnose breast cancer in its early stages. Since the device was first marketed in 1995, over 3 million procedures have been performed.

Ethicon Endo-Surgery, an operating company of Johnson & Johnson, worked with Prent Corp. (Janesville WI) to devise a solution for managing the tubing that connects the newest Mammotome biopsy probe for use with magnetic resonance imaging (MRI) with the system’s control device platform. The control system is located outside the MRI suite where the patient is examined.

The MRI Tube Set gained a 2006 Ameristar Award for Medical Packaging from the Institute of Packaging Professionals. Paul Marshall, EES senior packaging engineer, praises the solution as “a package that takes ownership of the coil control.”

“Prent came up with a simple design solution, using an established packaging medium in a completely new application, that enhances the customer experience,” says Marshall.

EES delivered tubes coiled in rigid trays covered with central supply room (CSR) wrap and pouched in a header bag. Though six to eight feet of tubing was initially supplied, the company needed to provide 30 feet of tubing to MRI customers. “The long tubing could become a tangled mess,” says Kevin O’Brien, EES staff packaging engineer.

Prent’s blister shell package contains, manages, and dispenses the tubing, as a fixture on the MRI cart.

O’Brien says that Prent quickly turned around prototypes as EES and Prent engineers evaluated alternative designs, and refined the final configuration, with input from an EES hospital customer.

“We needed a user-friendly solution. It came down to maintaining the simplicity and intuitiveness of the design, where one end of the tube is accessible, and the other end retained in a way that the tube doesn’t tie up when it’s pulled,” O’Brien says.

Three other designs were considered, says Mark Talabac, Prent sales representative. A sealed Tyvek-lidded tray with a cavity into which the prewound tube would be dropped, and a trifold package for dropping in the precoiled tube before lidding were options. Also studied was a three-piece part with a dispensing wheel that would rotate when the tube was pulled.

In the final design, the two-piece package is snapped together. One blister side features a loading die-cut for fixing the package for tube loading at the contract packager. One end of the tube is fixed into the blister and the tube is wound into the package on a tabletop fixture. The blister is then pouched and sterilized. Tube ends are captured in the tray to prevent puncturing the pouch.

U-shaped channels that form a track for the tubing were optimized to support ease of use and minimize the chance of the tube being cut during loading and unwinding.

A hang feature die-cut supports mounting the package to the control system cart. EES added posts for holding the Tube Set below the cart’s top.

PETG was chosen for its clarity that assists operators hanging the package on the cart, its structural characteristics for loading and holding the package weight, and its recyclability, says Talabac.

The package can be separated for removing the whole tube, or kept intact for unwinding through a gap be­tween the two sides.

“The tube un­winds like a ball of string,” says Mark Ralph, senior designer, Prent.

Prent determined that normal flanges used in a rigid tray might abraid the pouch, and would inhibit package flexibility. “We wanted some flex in the package to support pouch loading and unloading,” says Ralph.

The package features a zero flange design made with a standard in-line low-cost steel-rule-cut die. The alternative was using a $10,000 match metal die that was deemed overkill for the project, says Ralph.

Copyright ©2007 Pharmaceutical & Medical Packaging News