Information

About the Button Huggie

The Button Huggie project was started in 2016 by Dr. Steve Moulton, a pediatric surgeon at Children’s Hospital Colorado. It was born from the frustration of dealing with a multitude of gastrostomy button related problems on an almost daily basis, the clear absence of a solution, and the knowledge that a growing number of children and adults are living with low profile enteral access devices. It all started with two grants from the CU Department of Surgery, which enabled Dr. Moulton to sponsor a group of graduate students in the Department of Mechanical Engineering at University of Colorado Boulder. It was there that Dr. Moulton met Tyler Mironuck, one of the graduate students on the project, who immediately shared the same passion and unique vision for solving the complicated issue at hand. After four years of development, Dr. Moulton and Mr. Mironuck formed EZaLife, LLC to bring the Button Huggie to market.

The Science

Ten years ago, 50-60% of children who had creation of a gastrostomy underwent percutaneous endoscopically guided (PEG) gastrostomy tube placement. Nowadays, laparoscopic primary g-button placement has largely supplanted PEG placement, due to fewer major post-operative complications. Unfortunately, complications do still persist with g-button placement, which include pain and discomfort, leakage, infection, granulation tissue formation and accidental dislodgement. While the exact causes for these symptoms vary , it is theorized that lack of g-button stability is a primary factor. When a g-button is exposed to external forces (clothes catching, accidental hand swipe, etc.) and human-related forces (twisting of the abdomen, skin folding, coughing, etc.), there is shearing between the g-button and the skin and widening of the stoma.

G-button Diagram

We believe inhibiting movement of the g-button relative to the surrounding skin will reduce the chances of accidental dislodgement and less stress on the stoma, so that the gastrostomy tract can heal faster.

Current Standard

The most common method to secure a g-button consists of a 2x2 inch piece of gauze, which is placed under the button, both of which are then secured with tape; this is known as the tic-tac-toe dressing.

Information Tic Tac Toe Method

While this dressing provides some stability to the button, leakage remains a problem because it requires frequent changing of the gauze, and therefore frequent removal and reapplication of the tape. This can be painful for the patient and lead to medical adhesive related skin injury. Importantly, this dressing offers limited reduction ofof external forces applied to the g-button. The g-button still moves up and down and side to side in the gastrostomy tract, which delays healing and leads to a variety of common and distressing complications.

The Button Huggie Solution

With no product on the market to reliably secure gastrostomy buttons and address the myriad of problems associated with healing of the gastrostomy tract, we decided to invent one. Over 500 design iterations, and two small clinical trials of prototype devices have led to the first gastrostomy button securement device on the market, the Button Huggie.

The Button Huggie Solution

There are several unique design elements to the Button Huggie. The top layer is a washable, reusable lid, which helps to reduce cost and lower the impact of plastic on the environment. The middle layer is a highly absorbent, biodegradable, replaceable gauze sponge. Finally, the base layer is a uniquely contoured semi-rigid supportive structure bonded to a long-wearing, silicone-based 3M® adhesive.

The Button Huggie Layers

Painless Gauze Replacement

A defining feature of the Button Huggie is how it simplifies replacement of the absorbent gauze sponge as often as necessary, without having to remove the adhesive every time. This was achieved by incorporating the concept of a lid that can be opened to provide easy access to the gauze. The caregiver or patient can then simply slide out the soiled gauze and replace it with a new, sterile gauze pad. Closing the lid keeps the gauze pad secured under the g-button, while also providing an extra layer of protection from external forces.

The Button Huggie Gauze Replacement

The inner structure of the base layer acts as a holster for the g-button—always keeping it stable . It also facilitates replacement of the gauze pad under and around the g-button--a process that is quite cumbersome with the tic-tac-toe dressing. The 3M® adhesive allows the Button Huggie to be worn on the body for up to seven days. Once the adhesive wears out, the device needs to be removed from the body the base layer replaced. This means that the adhesive only needs to be removed from the skin once per week, compared to sometimes multiple times per day with the tic-tac-toe dressing.

Child-Proof

The lid and base layer are attached to one another by pulling the lid into the recess at the back of the base layer. This creates a childproof hinge between the lid and the base layer; importantly, the two components can only be attached or detached from one another when they are separate from the child. This is particularly important in that it mitigates the risk of a choking hazard. While the lid can be opened and closed to replace the gauze pad, it can only be fully removed from the base layer once the whole device is off the body.

Child-Proof

360° Protection

One of the most important roles of the Button Huggie is to provide 360° of protection from external forces. In our testing, we found that when the Button Huggie is applied, it reduces external forces on the g-button by up to 90%.

G-Button Subject to an External Force

This means that if a hand were to accidentally strike the g-button with 10lbs of force, and the g-button is secured with the Button Huggie, the actual force exerted upon the g-button would be reduced to only 1 lb.

24/7 Protection

Another feature of the Button Huggie is its ability to always secure the g-button, even during feedings. Because the g-button’s main function is to act as a long-term nutrition delivery system, it is important that the Button Huggie accommodate attachment of the feeding tube to the g-button without sacrificing securement. To do this, there is an opening on the top of the lid that allows connecting the extension feeding tube to the g-button without opening the lid. Once feeding time is over, the extension tube can be removed and the feeding port recapped.

24/7 Protection

Intelligently Designed

The gastrostomy button must be stabilized when attaching or removing the extension feeding tube, to minimize movement of the g-button in the gastrostomy tract, which can be painful. To achieve this, “edge grippers” were designed inside the base layer. When the lid is closed and pinched, the internal structure of the lid engages the inner template of the base layer, which stabilizes the g-button, limiting movementin the gastrostomy tract.

Intelligently Designed

Ergonomic

Another feature of the device is the three horizontal slits that are incorporated into the semi-rigid lid. The slits provide ventilation and promote end-to-end flexibility for accommodating the curved anterior abdominal wall of infants. These slits also promote side-to-side flexibility and make it easier for the user to hold the g-button when attaching the extension feeding tube to the feeding port.

Ergonomic

The Button Huggie Difference

Current Approach

Tic Tac Toe Method

Tic-Tac-Toe Method

  • G-Button secured protection
  • No force reduction from impacts
  • Feeding tube not constrained, resulting in potential hazard
  • Gauze replacement requires tape removal (sometimes multiple times per day)
  • G-Button not stabilized during gauze replacement
  • Dislodgment is common

Our Approach

The Button Huggie

The Button Huggie

  • 360° Protection
  • 90% external force reduction
  • Protection while feeding
  • Painless gauze replacement
  • Stabilizes extension is easy
  • G-Button still stabilized during gauze replacement
  • Only requires removal of adhesive once every 1-2 weeks
  • Prevents dislodgment