A New Lenox couple has proven first-hand the old saying, ”Necessity is the mother of invention.”
Necessity, in this case, was a matter of life or death-which can be a powerful motivator, particularly when the life to be spared is one`s own child.
With no medical training or previous inventions to their credit, Amy and Mike Vines clearly acted out of desperation to create a new medical device that now not only helps their young son, Tracy, but may also benefit thousands of others.
Amy puts her motivation in simple terms: ”It was a matter of wanting a good night`s sleep for me and my son.”
But that`s a little like the mountain climber who reaches a craggy summit only to explain, ”I just thought I`d stop for the view.”
The result may be carefree . . . but getting there is a problem.
The point that the Vines have reached is launching Tracy Medical Resources (TMR) Inc. in Lisle, where their invention, the Tracy Support, is now made available to the medical community and to other frantic parents like the Vines once were.
The Tracy Support is basically a sheet with an attached diaper-type restraint that positions patients in bed, yet provides some room for movement. The support is adaptable to hold the patient on his back, stomach or either side.
On an elevated bed, the support keeps even the youngest child from sliding down.
”It seems so obvious, someone should have thought of it before,” said L.E. Keith, a Chicago pediatrician for the last 36 years.
In his practice, Keith, who is affiliated with Children`s Memorial Hospital and Rush Presbyterian-St. Lukes Medical Center in Chicago, sees both 5-year-old Tracy and the Vineses` daughter Sarah, 9.
The fact that the Vineses have developed a potential lifesaver is remarkable, Keith said.
”It is extremely unusual. In the general area of medical equipment, I don`t know how many parents have proposed devices. In my limited experience, it`s the only time I`ve seen it. I`m really proud of them.
”It reminds me of when the guy discovered the paper clip,” Keith said, laughing. ”It`s so simple, after someone describes it.”
The impetus for the Tracy Support is a happy blond-haired, brown-eyed preschooler, if perhaps a bit small for his age. Like many of his peers, Tracy Vines is fascinated by dinosaurs and can easily distinguish between a triceratops and a brachiosaurus for a visitor.
He enjoys watching singers ”Sharon, Lois and Bram” on television and is a water lover who was recently promoted two levels in swimming class.
But unlike most others, Tracy suffers from gastroesophageal reflux, a gagging disorder normally diagnosed in infancy. At the point where the esophagus empties into the stomach, there is a muscle. Normally, this muscle opens the passageway into the stomach when you swallow and then clamps shut.
Tracy was born with a defect in this essential valve. So the contents of his stomach can easily come back up to cause serious complications in swallowing and breathing.
An estimated 364,000 cases are diagnosed annually, according to TMR figures.
Dr. Keith puts the situation in practical terms: ”You can eat a three-course meal and stand on your head and you don`t have to worry about your stomach emptying its contents through you mouth. If Tracy were to do that, he`d be in trouble.”
Before the Vineses` invention, Tracy was in trouble. Every night. That`s because the danger increases when Tracy lies down. He wheezes, coughs and labors to breathe. His condition requires that he stay upright or at least in a semi-upright position, even when sleeping.
”We still had to go about our daily responsibilities and then every night it was terror time,” said Mike Vines, Tracy`s father. ”We never could really sleep. We`d either take turns sleeping or sleep on the floor next to him or have him in the bedroom with us.”
The trouble started when Tracy was a baby. But the Vineses chalked it up at first to colic, then croup, and finally allergies and asthma. (Sarah, who just finished 3rd grade at Haines Elementary School in New Lenox, suffers from allergies and asthma but not the gastro-reflux problem that her brother has.) ”When Tracy was in a crib, we`d keep the crib elevated all the time” by adjusting the hooks that held the mattress in place, Amy recalled. ”Then we came to the age when he went from the crib to the bed. So of course, it was a flat bed. That`s when he started having the croup constantly.”
In a panic, they would jostle Sarah out of bed, bundle both children and rush to medical attention.
”We took Tracy to the emergency room a couple of times and by the time we could get there, he`d be perfectly fine. They`d look at us like, `Mom and Dad, settle down`-like we were crazy,” said Mike, explaining that in hindsight, it was the upright car ride to the hospital that had eliminated the problem.
The situation was frightening and puzzling, especially since Tracy generally didn`t appear sick. Unlike typical illnesses, there was no fever, weakness or loss of appetite.
Thinking he was suffering from croup, and discovering he was more comfortable upright, they were propping him up with ”zillions of pillows,”
noted Amy, even trying to have him sleep seated in his stroller.
”Tracy is not a big boy, but around the house we nicknamed him `Moose,`
” said Mike. ”He would be so desperately ill at night and the next day he would be playing like there was nothing wrong. We just thought, `This guy`s as strong as a moose!` ”
Mike, who is the corporate director of risk management for the Mokena-based Franciscan Sisters Health Care Corp., described Tracy`s symptoms to an allergist he knew. The doctor said he doubted the illness was related to allergies.
”So the next time Tracy had an event, we just put the pedal to the metal and went to Children`s (Memorial Hospital) ER,” Mike recalled. An assessment was done, and within just 15 to 20 minutes, Tracy was diagnosed with gastroesophageal reflux.
That was November 1989, and Tracy was 2 1/2.
Now the Vineses had an answer, but it was an answer that prompted a hundred more questions. Their ignorant bliss came to a crashing halt.
”Right then they said he`s at risk of dying,” Mike said. ”If he lies down, he could aspirate back into his lungs.”
Although they had already recognized their son`s difficulties, hearing it from the doctors made the situation all the more grave. Added Mike, ”It was so terrifying for us.”
Options for treatment included a restricted diet, radical surgery, medicine or elevation. The Vineses immediately agreed to a careful diet and eating schedule, and continued efforts to raise the bed to a 35- to 40-degree angle. But, naturally, the youngster would slip right down.
To restrain Tracy, they were offered wrist tethers, which basically tied the child`s wrists to the bedpost. But the psychological effects of sleeping tied up concerned both parents and doctors.
They chose instead the only other option, a waist restraint, even though it meant they would have to turn Tracy every two hours to prevent bedsores.
One Saturday, just a couple of weeks after the diagnosis, Mike went up to check on his napping son.
”Tracy had slipped his arm through the restraint and was hanging himself and literally turning blue,” Mike recalled. ”When Amy came home, I was frantic and said, `This is unacceptable. What can we put him in?` But there was nothing else out there.”
At wit`s end, Amy sat down at her sewing machine. She made a diaper that was secured with Velcro. This she sewed on to a large piece of sheeting, leaving enough freedom to let Tracy roll some without having to be moved regularly through the night.
”Then it was just a matter of making slight adjustments,” Amy said. ”I got to where I could sew them in my sleep.”
Each of Amy`s design changes brought the family closer to a solution. Finally they felt comfortable with what is now known as the Tracy Support, a safe, secure restraint that held their child positioned in bed.
To the Vineses, a burden was lifted. For almost the first time in Tracy`s life, they could all get a good night`s sleep. It was the end of ”terror time.”
An episode from one of Tracy`s hospital stays haunted Mike, resulting in the family deciding to make the device available to others. During that hospital stay, Mike noticed a toddler in the next bed who was recovering from extensive facial reconstructive surgery. That child`s bed was elevated too.
”I asked the dad, `What are you going to do when you go home?` He told me, `We`re going to stand next to the bed like we`re doing here right now.`
”They had no way to safely keep him in that position until he recovered,” Mike recalled haltingly.
Clearly moved, he continued: ”I don`t know how you can know you have something that could help those kind of people and keep it to yourself. That was a real motivating incident for me.”
Amy and Mike took their invention to Dr. Keith and Dr. Lauren Holinger, the otolaryngologist (ears, nose and throat specialist) who had diagnosed Tracy`s condition at Children`s.
The doctors and nurses they approached were impressed.
Said Holinger recently, ”There was nothing really successful that could be used. That`s why the Tracy Support is quite an important help in managing these children. I think it`s going to be helpful in the medical profession in a variety of ways. It`s a much kinder way of restraining patients and gives them more freedom than anything we have to date.”
With such a positive reaction, the Vineses moved forward. Dennis Evanson, a lawyer who specializes in start-up businesses, was brought in to serve as president of TMR. A search found nothing like their invention on the market. Evanson filed the applications for FDA approval, which was granted in 1991, and a patent, which is pending.
The group raised about $7,000 to manufacture nearly 200 Tracy Supports. These were donated to Children`s Memorial in August of 1991 for clinical trials.
(Evanson said that testing of an adult version, and one for wheelchair use, will soon begin in a nursing home setting.)
The three-month trial at Children`s found many uses in post-operative, orthopedic, digestive and other conditions.
Mary Buechlein, formerly a nurse manager at Children`s, was co-chair of the new products committee when the Tracy Support was introduced.
”I saw a lot of stuff in that role,” she said. ”But when I saw something that I thought was good for kids or their parents, I`d do what I had to do to help it go. I really liked the Tracy because it can do so much good.”
In fact, Buechlein liked the device so much, she left her post at Children`s after four years to join TMR in January as the company`s clinical marketing consultant. Buechlein now presents the product to nursing staffs and medical institutions.
Today, more than 25 hospitals in the Chicago area are using the Tracy Support, which is being produced by a medical textiles firm in Alabama. The cost is about $58 for each support, and the company has sold only 30 to 40 dozen as it moves slowly into the market. On the drawing board are a couple of other new products.
”Right now we`ve just concentrated on the Chicago market, we`re in such an embryonic state,” said Mike, who serves as TMR chairman of the board.
Waukegan`s St. Terese Medical Center has tried the Tracy, which Jean Coleman, pediatric manager, described as ”wonderful.”
Said Coleman, ”The staff was very pleased with it. It kept them (the patients) stable, yet there was room for movement and they could still hold their bottle.”
At Edward Hospital in Naperville, assistant pediatric manager Cindy Montgomery reports that the Tracy Support is on order.
”Up until this, we have used sheets, sandbags and pillows,” Montgomery said. ”This should eliminate the hodge podge.”
The device certainly did that, and more, for the Vineses.
”Bottom line is you`re always going to have adversity in life,” Mike said. ”If Tracy having this kind of problem saves another child`s life, it`s worth what we went through.”
