SURGERY
Advances and Answers in Pediatric Health
2 Inventions in : Pediatric Surgery
Is there a better way to secure gastrostomy buttons and central venous catheters than tape and gauze ?
Pediatric surgeon Steven Moulton , MD , places a lot of gastrostomy buttons . Most pediatric surgeons do . Worldwide , about 2.5 million of these feeding tube devices will be placed or replaced this year . That figure is expected to exceed 3.5 million by 2021 .
“ And they ’ re fraught with problems ,” says Dr . Moulton , who also serves as Director of Children ’ s Hospital Colorado ’ s Trauma and Burn programs . “ If you make a new hole in the stomach , it ’ s going to leak . The gastric contents are acidic , which can cause a skin rash . It ’ s moist , so that can lead to a skin infection . And gastrostomy buttons can be accidentally dislodged . I often overhear nurses on the phone with parents , who have constant problems with these devices . And the only things we ’ re giving parents to secure them are tape and gauze . I thought , ‘ There has to be a better way .’”
1 . The Button Huggie
A $ 25,000 seed funding grant was enough to pull together a team of mechanical engineering graduate students at the University of Colorado Boulder . The problem was a complicated one .
“ We had to balance securing the gastrostomy button with facilitating changing the gauze pad and stabilizing the device . It needed to provide ventilation for the gastrostomy site , and it had to be childproof . We also wanted at least one component to be reusable ,” says Dr . Moulton . “ We went through hundreds of iterations . Hundreds .”
One discovery , suggested by research assistant Tyler Mironuck , was an inner structure that acts as a guide for securing the gastrostomy device and facilitates replacing the gauze sponge around the button ’ s stem .
The resulting device , known as the Button Huggie , won the Children ’ s Colorado Center for Innovation Challenge in 2019 , providing an additional $ 40,000 in funding . These funds are being used to support a 200-patient clinical trial that will start this fall at several pediatric hospitals , including Children ’ s Colorado , Phoenix Children ’ s , Primary Children ’ s and Stanford Children ’ s .
2 . The Snuggie
Under Food and Drug Administration rules , the Button Huggie didn ’ t count as a new device , since its purpose was to secure a device that was already cleared by the FDA . That saved considerable time and expense in the approval process . And it got Dr . Moulton thinking : What other surgical devices need to be secured ?
One obvious choice was external tunneled central venous catheters , which are inserted in a vein to facilitate access for chemotherapy , lab draws and a host of other applications . These are held in place by a Dacron cuff under the skin . Over the course of about four weeks , subcutaneous tissue grows into the cuff and secures the catheter . The trouble is those four weeks .
“ And if the patient is sick or immunocompromised it could be eight weeks or longer ,” says Dr . Moulton . “ And in the meantime , the catheter is just dangling , waiting to get caught on something .”
There ’ s also the risk of bacteria migrating up the catheter and around the unsecured cuff , infecting the bloodstream .
With a $ 25,000 grant from the Children ’ s Hospital Colorado Center for Children ’ s Surgery , Dr . Moulton assembled another team at CU Boulder with a new challenge and a new set of requirements . The securement device could not change the method nurses were familiar with for dressing the exit site . Nor could it crimp or in any way damage the catheter , which could cause blood leakage or infection or require an operation to replace the damaged catheter .
“ The design we came up with is completely separate from the exit site , so it doesn ’ t change the method of dressing at all ,” Dr . Moulton says . “ And it simplifies the management of the hub and greatly reduces the chances of dislodgement .”
A 20-patient clinical trial to test the first Snuggie prototype device will start in the next month or two . •
The design of the Button Huggie , created to secure gastrostomy buttons , went through hundreds of iterations .
The Snuggie secures external tunneled central venous catheters without interfering with dressing changes .
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