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Comfort Line: A Garment to Secure Central Lines

In October 2009 our infant son Ian, approaching his first birthday, was admitted to Johns Hopkins Children's hospital with a Fever of Unknown Origin (FUO). Shocked, scared and concerned we spent several nights sleeping next to our son's crib at the hospital not knowing the cause of these fevers.

After 3 days at the hospital, a routine sonogram was administered on Ian's abdomen after a urinalysis turned up a slightly elevated white blood cell count. The resulting sonogram revealed that Ian's bladder was slightly out of normal position. He was immediately sent for a follow-up CT scan. Upon medical review of the CT scan, we were taken to a conference room in the hospital joined by Ian in a Radio Flyer pull wagon. Several Doctors sat with us to explain what the CT scan had discovered. Upon placing the films on the light-board, the Doctors began to point out numerous areas inside our son's body which showed as large "white" areas. From his lower abdomen all the way up behind his heart, he had developed cancerous masses that needed to be identified via biopsy.

To say that this was a parent’s worst nightmare, is an understatement. As I am recounting this event, it is difficult to hold back the tears as the fear wells up inside my chest again. There is just no way to prepare yourself for something like this. The meeting with the Doctors took place on a Friday evening and with the medical staffs best efforts they could not assemble the needed surgical team until Sunday morning. This was the longest 24+ hours I can remember, time just could not move quickly enough.
When Sunday morning finally arrived, Ian was taken to the OR for a biopsy and to have a Hickman central line catheter (CVC) placed in his chest for medications and blood work. Later that day, our Attending and Fellow Oncologists arrived to present the preliminary lab results for the biopsy. Ian's diagnosis appeared to be Non Hodgkin's Type-B Lymphoma, a very aggressive cancer. His chemotherapy treatment began later that evening.

With assurances from our Oncologists and now knowing what we were dealing with, our deepest fears were halted for the time being. We knew we still had a long road ahead of us. Ian spent almost a week and his first birthday in the hospital receiving his initial chemo treatment. We were shocked later that week when we were notified that we could return home with Ian, and that many follow-up treatments would be administered by nurses that would come to our home.

While still overwhelmed from all that we had just been through, we returned home with our 1 year old son, who now had a central line device secured to his body with adhesive dressings and surgical tape. We had to learn how to care for our son all over again, as unique challenges presented themselves. An active baby boy, with a delicate medical device inserted into a major a vein exiting from his chest posed constant cause for concern.

As a point of potential infection for an immunosupressed baby, we struggled with how to properly care for our son and his central line. Here are a few of the daily difficulties living with a central line:
  • Proper containment and securing of the line when it is not being used, without causing discomfort, skin irritations or sores.
  • Keeping the line ports clean and preventing exposure to germs or bacteria.
  • Preventing the line from getting accidentally tugged or damaged.
  • Maintaining easy access to the line ports for doctors and nurses.
  • Preventing tangles or crimps in the line while connected to medications, and during sleep.
  • Changing clothes easily and regularly when connected and not connected to medications (on a squirming little boy in diapers).

We were shown by nurses the two current means for managing, securing and containing a central line:
Surgical taping the device directly to the chest skin.

OR

Wrapping the device with surgical tape, and safety pinning it to the inside of the shirt.
Needless to say, both of these methods pose issues to the wearer and the device. Constant application and removal of tape from the skin produces irritations and can lead to open sores, for someone with no immune system this can pose a serious problem. Securing the line by pin can lead to accidental pulling of the line and potential damage to the device or complications to the wearer requiring additional surgery.

My wife set out to “uncomplicate” the challenges we now faced with Ian’s care. Having made her own dresses and clothing items growing up, she created an infant garment that had a small pass-through hole allowing access to the central line during treatment. During our first extended stay at the hospital for chemotherapy, we learned that we still had a lot to learn before this infant garment could really be functional and truly help us protect and care for Ian’s central line.

As the months began to pass, and more hospital stay chemotherapy was needed, the infant garment had gradually evolved to properly address all of the challenges we had listed. We knew that a corner had been turned when our concerns began to abate, and we stumbled into an unexpected situation. While attempting to care for our child and his central line, we were persistently garnering the attention of Doctors and Nurses and other parents at the Children’s hospital with comments like…
  • Where did you get that garment?
  • Do you have more of those garments?
  • I have never seen anything like it for central line care.
  • When can we get some of these garments?
  • You have made something special.
  • Did you design this yourself?

With the trials and experiences we had accrued over the first year of Ian’s treatment, we decided to speak with a patent attorney to help put some perspective on all the comments we had been receiving regarding our little garment. After our first meeting and some preliminary research, we were surprised to discover that we had inadvertently created something truly unique. With no guarantee of success, and the prospect of significant legal fees, we had a decision to make. Ultimately it came down to our strong desire for giving back to others living with a central line and all the incredible medical professionals who helped save our son’s life. These were things which could not be assigned a “dollar figure”. We took a deep breath, and committed our garment design to an application with the United States Patent Office in 2010.

At long last, we received confirmation from our attorney on December 17th, 2013 that our Garment for securing an external portion of a catheter had received U.S. Patent No. 8,607,366 B2. We could not believe it, our journey through darkness and tragedy had produced something positive.. a healthy little boy and the garment he inspired. We now had the opportunity to provide hospitals and patients a working product for managing and caring for a central line device. The Comfort Line medical garment has also incorporated the usage of Agion anti-microbial textile technology for superior product protection.

As the parent of a little boy who is now a cancer survivor, life takes on a significantly different perspective. There were countless medical professionals some of whom we never saw that all played a role in our son's positive outcome. While many of them say "this is just my job" or "the patient was responsible for the positive results", anyone who has been through an experience like this knows that these very special medical professionals dedicate their lives to help heal. We feel that it is now our obligation to support them and help provide a quality of care to patients and families living with a central line device.

Our intimate understanding of central lines and the challenges that they pose to both patients and caregivers helped to define our mission. We know we can play a strong role in central line safety and protection and look forward to supporting patients and healthcare providers everywhere.                                                                
David Austin
CEO, Co-Founder
Comfort Line, LLC   

David Austin is CEO and Co-Founder of Comfort Line, LLC, a Baltimore, Maryland based company that produces patented medical garments for safeguarding patients central line catheters. David has spent many years gaining an expert knowledge of central line devices and the challenges they pose to patients and care providers. He also specializes in textile anti-microbial biotechnology, manufacturing and product design. David is also an advocate for patient safety, quality of care and HAI/CLABSI prevention. As an acting advisory board member for Make-A- Wish Mid-Atlantic, David is on a mission to support patients and medical providers managing central line safety.

As the parent of a cancer survivor, David has an intimate understanding of the secondary complications, risks and safety concerns associated with central line devices. You may read more about David and the Comfort Line medical garment design at: http://www.mycomfortline.com

Posted: 8/17/2015 1:15:40 PM
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