How plastics are shaping medical design excellence

A finalist in the 2017 Medical Design Excellence Awards (MDEAs), the Tube-Evac device is designed to safely and simply remove fluids from tubing attached to surgical drains so that they do not flow back into the patient. Unlike other drain-clearing devices on the market, Tube-Evac prevents overstretching and distortion of the tubing thanks to an inventive design, a durable polymer and a moldmaker’s expertise.

Vance Shaffer, President of Godsdvc (Crystal River, FL) and inventor of the device, noted in his MDEA submission that nurses and patients must be attentive to the amount of pressure they place on conventional drains when stripping them of fluid and debris to avoid stretching the tubing. It is not unusual for surgical tubing to double in length when this method is used, said Shaffer. His solution involves an injection molded clamshell device embedded with rollers. He described the operation of the device, as follows:

“When [the clamshell is] opened, each side of the device has a groove for placing the tubing. It also has a roller embedded in each side of the clamshell and when the clamshell is closed the tubing is almost completely flattened by the rollers. As the device is rolled down the tubing, it pushes the fluid and debris ahead of the rollers into the collection bulb. No friction is placed on the tubing and, thus, it is not stretched.”

Easy operation is especially important since the device typically is sent home with patients for use during recovery. The single-use product is discarded once the drains have been removed from the patient.

Tube-Evac

Shaffer’s design eliminates friction between the tubing and the sides of the device, and ensures that the tubing is always properly positioned. He worked with Plastic Concepts and Design (Jacksonville, FL) and Ameritech Die & Mold South (Ormond Beach, FL) to develop the tooling and select an appropriate material. After a first mold iteration that proved to be too costly, they settled on a four-cavity tool and separate die with rollers. Seeking a material that would bend back and forth 1000 times without breaking, Shaffer opted for a polypropylene grade provided by Pinnacle Polymers (Garyville, LA). He added that he knows of one Tube-Evac device that has been in use for five years and been opened and closed thousands of times without breaking.

The Tube-Evac product is packaged, distributed and invoiced by Lighthouse for the Blind, which employs blind people.

The winners of bronze, silver and gold awards in the 2017 MDEA program will be announced during a special ceremony and reception on June 13 at Medical Design & Manufacturing (MD&M) East. The event, co-located with PLASTEC East, comes to the Jacob K. Javits Convention Center in New York, NY, from June 13 to 15. For more information and to register to attend, go to the event website.

It is also worth noting that the product sells for $5 per piece, prompting one buyer at a major hospital to say that the device is “way underpriced.” However, “we wanted to make sure that it is affordable to those with very little income in case the hospital charges for it,” said Shaffer. The company has also received requests from patients wanting to buy it for themselves. Since it does not sell to individuals, the firm typically will overnight a Tube-Evac device to them at no charge. “In return we have been taken out to eat, invited to very nice homes for dinner, promos have been offered, letters of thanks have been sent to us and videos have been done for us,” said Shaffer. 

And that is pretty darn cool.

Here are capsule descriptions of a couple more MDEA finalists where plastics play a visible role in the aesthetics and functionality of the device.

Abbott FreeStyle LibreThe FreeStyle Libre, developed by Abbott Laboratories (Alameda, CA), is described as a first-of-its-kind glucose monitoring system that eliminates routine finger pricking. It is a finalist in the Testing and Diagnostic Products and Systems category.

The device consists of a sensor and reader. The sensor, which is about the size of a quarter, is worn on the upper arm for for up to 14 days. During that time, it tracks glucose levels without requiring a finger prick to calibrate. The patient can swipe the sensor with the reader at any time to download glucose levels. The device provides users and practitioners with an overview of glucose levels, patterns and trends over a 14-day period.

Medtronic SigniaThe Signia powered stapling system from Medtronic (Dublin) uses an algorithm to provide surgeons active feedback related to target tissues and to adjust the firing speed to optimize staple formation. Parts of the device are reusable while others are designed for single use. Contract manufacturer and molder Phillips-Medisize (New Richmond, WI) is among the companies credited by Medtronic as a supplier to this project.

The device is competing in the Radiological, Imaging, and Electromechanical Devices category.

EargoFly fishing was the surprising inspiration for a novel hearing aid technology that is a finalist in the Rehabilitation and Assistive-Technology Products category. The invisible, rechargeable in-ear device developed by Eargo (Mountain View, CA) incorporates proprietary silicone-based Flexi Fibers that mimic the fibers of a fishing fly. The Flexi Fibers suspend the electronics in the ear canal. Because the Eargo device doesn’t block the ear canal, some pure, natural bass sounds are able to pass right through, wrote the company in its MDEA submission form. Consequently, the sound quality is exceptional. The product also is rechargeable, eliminating the need to buy costly hearing aid batteries, and the charge lasts the entire day.

To see all of the MDEA 2017 finalists, check out this slideshow published by sister brand MD+DI. And to find out which companies will be bringing home the gold, silver and bronze, be sure to attend the special ceremony and reception on June 13 at Medical Design & Manufacturing (MD&M) East.

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