by Sarah Gray
“We were thrilled,” said Bethany.
The Conkels were joined by twenty-seven friends and family members and spent the rest of the day taking pictures of Amalya, making prints of his hands and feet, and giving him lots of hugs and kisses.
“We even had a birthday party complete with cupcakes, a ‘birthday boy’ hat, a ‘zero’ candle, and a tear-filled round of ‘Happy Birthday,’” said Bethany. “Joy overflowed from our room that day. I can’t even describe in words what it was like.”
Because the Conkels chose to participate in whole-body donation, Amalya’s body needed to be cooled within twelve hours of his passing. Each family member said a final good-bye and then left Bethany and Eric to have a private moment with their son.
“Finally, we called for the nurse and handed our sweet boy over for the last time. The moment I let him go, my heart shattered. It was the hardest thing I’ve ever had to do. I was so in love with this sweet gift from the Lord, but I knew it was time for him to fulfill the rest of his purpose here on this earth.”
Because of all the confidentiality protocols, all the Conkels knew was that Amalya would be studied by researchers somewhere in the United States. They wondered who would hold him next. That’s when Bethany got an idea.
“Do you have a marker? A black Sharpie or something?” Bethany asked Eric. “I want to write a note to the researchers.”
Eric searched his backpack.
“All I have are these two highlighters,” Eric said, holding up one pink and one green one.
“They’ll do,” Bethany said.
Eric and Bethany each made a thumbprint in the shape of a heart, and under each one wrote “Mom” and “Dad” in green. Below the hearts, they wrote in pink, “We hope he helps. Use him well.”
Bethany and Eric left the maternity ward for home two days later. They were led through a back door so they didn’t have to walk past the happy new families in the lobby.
On the way home, Bethany’s phone rang. It was 11 A.M.
“We just wanted to let you to know that Amalya’s flight has departed. He is on his way to the research facility now.” Bethany Conkel felt a glimmer of hope.
Over the weeks that followed, Bethany and Eric learned more about where their son’s donations went. Amalya’s cord blood was sent to the Duke anencephaly study, where Thomas’s and Callum’s cord blood had gone. Blood from his heart and a small sample of his skin was sent to the Coriell Cell Repository in Camden, New Jersey, to develop cell lines to be stored for future research studies. His liver went to a university in the United States to study liver disease, including cirrhosis. His pancreas went to another university in the United States for the study of pediatric diabetes. And the rest of his body went to an emergency-medicine facility in Texas.
In many cases, a donated whole body is studied by medical students to learn about every structure of the human anatomy. A deceased donor whose body has had some of the organs removed is not suitable for this kind of study. However, Amalya’s body, which was missing the liver and pancreas, was a suitable match for a special research project that involved the skeletal structure.
When an ER patient is dehydrated or in shock, his or her veins can collapse. When a vein can’t be accessed, paramedics have another option: they can use a drill-like device to make a small hole in the patient’s bone. This technique, called intraosseous access, or IO, was developed in 1922 by Dr. Henry Drinker, who first showed that it could work on, of all things, a rabbit. During World War II, the technique was used in the European theater to treat combat injuries.
Then, in 1984, James Orlowski, a physician from the renowned Cleveland Clinic who was working in India during a cholera outbreak, wrote an article in the Archives of Pediatric and Adolescent Medicine entitled “My Kingdom for an Intravenous Line.” In it, Dr. Orlowski lamented, “There is nothing more exasperating than the inability to establish intravenous (IV) access in a critically ill child.” Having repeatedly faced sick children with no “visible or palpable veins,” Orlowski advocated for intraosseous access, since just about any medication or fluid such as saline or blood could be administered this way safely because a bone is essentially a large vein that will not collapse.
As a result of Orlowski’s advocacy, IO was widely adopted in the United States for use in children, whose veins are smaller and can be more difficult to access through IV. For years, the most commonly accepted application site for pediatric cases was the tibia—the shin bone.
Scotty Bolleter, chief of the Office of Clinical Direction at the Centre for Emergency Health Science at Bulverde Spring Branch Emergency Medical Services in Spring Branch, Texas, is a passionate advocate of furthering the course of emergency medicine—and of improving the IO method. A veteran EMT and paramedic, he has trained thousands of physicians, nurses, physician assistants, and members of the military in what are called “advanced skills,” although Bolleter considers them fundamental skills: the techniques for saving a soldier injured in combat or the next patient brought into the ER by ambulance. In partnership with a company called Vidacare, Scotty redesigned the IO technology in a device they named the EZ-IO. This is a handheld device, about the size and shape of a hot-glue gun, with a thin, 1.5-inch needle at the end.
According to Bolleter, the tibia was not the best location to establish IO, because the compartments in the muscles near the tibia are in close proximity to the bone, and if the needle is not placed perfectly into the bone, these compartments will swell. This buildup in pressure is called compartment syndrome, and it can lead to the death of a muscle and even the loss of a leg.
Bolleter proposed an alternative location: the femur. The muscles around the femur do not have the same properties as the those around the tibia and do not cause as much swelling if a needle is badly placed. As a result, the risk of compartment syndrome decreases—and evidence from tests indicated that the femur bone allowed better fluid flow in any case.
Bolleter would need to prove this to the FDA in a process called a Premarket Notification 510(k) clearance. This is the process by which the FDA determines whether the new device is similar to a device that has already been approved by the FDA, and therefore does not need an entirely new and lengthy clearance.
“The 510(k) process is like, ‘Hey, Mom, that guy is doing it. Can I do it, too?’” said Scotty.
Bolleter and his Vidacare colleagues submitted their first 510(k) application for FDA approval of the femur location in 2007, and received their first rejection later that year, citing “lack of definitive proof” as the reason and asking for more detail. Bolleter was frustrated and heartbroken, but something kept him going.
“It had to be done,” Scotty said. He tried to think of something—anything—that might prove to the FDA what he knew to be true. In 2002 or 2003, he had tested the EZ-IO on two different deceased children—a girl and a toddler boy. But because both children had been embalmed, the fluid flow did not offer a realistic example of how the flow would proceed in real life, so his tests had limited usefulness.
“The adult world rapidly embraced the use of the drill, but they were worried about the pediatric uses. ‘It’s too powerful—you will never be able to safely use this on a child,’ and that kind of thing. They were scared,” Scotty explained.
It occurred to Bolleter that in order to show how the EZ-IO would really work in the real world, he would need to demonstrate the device on an unembalmed pediatric human cadaver.
“Infant donors are hard to get. It’s not that the researchers do not want these donors. It’s the lack of access. They are not available,” he said. Scotty placed a request for a deceased pediatric donor with the University of Texas Science Center in 2004.
Then he waited eight years.
In September 2012, Bolleter finally received a call asking if he would accept a neonatal donor from IIAM. By this time, not only was Bolleter still working on the EZ-IO, but he had an additional research project on airway management. He was trying to teach EMTs the differences
between the airway of an adult and the airway of a child, and he figured that this donor might be able to help both studies.
Less than a week later, Amalya’s body arrived via air freight at the Vidacare facility in Shavano, Texas. Bolleter and a member of his team opened the cardboard box labeled Human Remains. Inside was a casket covered with frozen gel packs. And inside the casket lay tiny Amalya.
“I wasn’t shocked,” Scotty said. “He looked peaceful, like he was resting. It was unusual that he had a note written on his clothing, but it was welcome. The way I run my division, we are open to families and the discussion.
“The folks who work in human anatomy—we talk to specimens. We know all their names; we use their names. If we are pulling someone out of a cooler and their head falls hard on the table—well, my staff apologizes immediately. It’s not like slinging meat. We treated Amalya the same way we treat all of our specimens.”
Scotty Bolleter considers himself lucky to have been taught this way. Throughout his training in health care, his teachers and professional mentors all treated deceased donors with care and reverence. He described a funeral at medical school where solemn physicians and nurse practitioners gathered to honor their “first patients” and say a silent “thank you” for what they would not have learned otherwise.
Scotty Bolleter had waited eight years for this donor, and he didn’t know when he might get this chance again. Bolleter’s team took as many pictures and videos as they could, including among their subjects the newly designed EZ-IO device as it was placed into Amalya’s femur and as it released fluid. Using fluorography—photography using fluorescence—Bolleter was able to successfully record and display the flow of fluid into Amalya’s bone using the EZ-IO. Even then, he wondered if these images might be the evidence the FDA needed to understand that this device had the potential to save human lives.
During the procedure, Amalya’s airway was also closely studied. Securing an airway quickly can be a matter of life and death in emergency medicine, and the airway of a child, especially the epiglottis, is different from that of an adult or a training dummy. Bolleter took pictures of Amalya’s epiglottis and trachea to show other medical professionals exactly what it looks like to place a chest tube into such a tiny airway. These images would be incorporated into teaching tools and presentations that would be shared with thousands of professionals and students all over the world.
In the meantime, Bethany contacted IIAM to see if there were any updates from the researchers.
She got some surprising news.
“Never in a million years did I think I would get this,” Bethany said. Vidacare had provided a two-page handwritten note to IIAM to be delivered to Amalya’s parents.
“Dear Mom & Dad,” it opened. The letter expressed condolences for their loss and gratefulness for their generosity. It explained that Amalya already had a complete set of X-rays and was part of a research and education effort that involved intraosseous vascular access. His contribution would undoubtedly save the lives of some of the world’s smallest and sickest patients. It closed with a plea that the parents never underestimate the magnitude of their son’s gift. At the bottom were seven individual signatures from members of the team, and handwritten messages reading “God Bless You” and “God Bless You and Yours.”
Bethany and Eric were floored. They read and reread the letter, and called her parents with the exciting news. The proud mom and dad created Christmas gifts for the researchers, which included a Christmas ornament and one of Amalya’s handprints.
Nine months later, a rep from IIAM called the Conkels to let them know that the Vidacare research was done. Amalya’s remains and his belongings would be returned to his family.
“Before the specimens go to be cremated, I write on their shroud the medical symbol for ‘with’—a C with a line on top—and a heart, for love,” said Scotty Bolleter.
In May 2013, the Conkels received a package at their Dayton home via Federal Express. Inside was a gold-colored box, about the size of a box that a bracelet might come in, affixed with a white label that read “This package contains the Cremated remains of Amalya Nathaniel Conkel.” Inside the box was cotton batting and a sealed plastic bag filled with ashes. Also included in the package was Amalya’s onesie with the message written in highlighter, his blanket, his hat, and some gifts from Vidacare: a cloth angel figurine, a knitted set of booties and a hat from an organization called Threads of Love, and a music CD.
Later that year, on October 30, 2013, Vidacare submitted the FDA approval application again, for the third time and with fingers crossed that these images would provide the evidence that was needed. Just over three months later, on February 11, 2014, the FDA published what is officially titled 510(k) NO: K132583 (TRADITIONAL). After seven years, three applications, and binders full of FDA questions and Vidacare responses, the FDA finally approved the use of the EZ-IO in the femur of children.
“The reviewer for the United States government specifically said, had it not been for those images, he likely would not have approved this particular usage,” said Scotty Bolleter. Through word of mouth, Bolleter already knows for sure of one child whose life was saved by this device and this location.
For the Conkels, hearing about all this was a dream come true. Through their donation, they were able to spare another family the loss that they faced. Amalya’s death had not been in vain.
But that is not all Amalya Nathaniel Conkel accomplished. The images and videos of Amalya’s airway have appeared before thousands of medical professionals in educational presentations and publications in countries all over the world, from New Zealand to Syria. Scotty Bolleter said that in the year 2015 alone, he personally presented Amalya’s images to at least ten thousand medical professionals, including the attendees of the Special Operations Medical Association’s annual conference, a gathering of professionals from the fields of wilderness, austere, and disaster medicine.
Scotty Bolleter and the Conkels were able to meet face to face in August 2014, at the Musculoskeletal Transplant Foundation’s leadership summit in New Orleans, and they presented him with one of Amalya’s handprints.
“Only once have I ever met a family before the Conkels, and you get a chance to say how they made a difference,” said Scotty. “Being able to complete that circle is critical; it allows you to move on the next important thing.”
“It was amazing to be able to meet him in person, and very fulfilling,” said Bethany.
For Bethany and Eric Conkel, donation brought healing. It gave Bethany what she called “Proud Mommy moments.”
“One of the hard parts about losing a baby at birth,” Bethany said, “is that you don’t get to watch them grow up; you don’t get to watch them reach their first milestones, take their first steps, say their first words, eat their first food. But donation allowed us to be proud of our son in a different way.”
On the third anniversary of receiving Amalya’s diagnosis, Bethany did something special to honor her son. Moved by the FDA approval, Bethany got a tattoo. Just above her kneecap, where the newly approved insertion site is, she has a delicately drawn heart that comes to a point in an A—for Amalya.
And Bethany wasn’t the only one recognizing Amalya.
“I have Amalya’s handprint in my office, facing east,” said Scotty Bolleter. “So the sun rises in his little handprint. He is representative of all of the donors that have come before and will come after. When I look at little Amalya’s hand, I think of all the donors who work here. It’s not just a carcass. It’s not just a body laying on a table.”
Scotty Bolleter is passionate about the contributions of these “voiceless teachers,” and frustrated by the shortage of deceased donors that are available for crucial, life-saving research.
“Think about the images that da Vinci drew—The Mechanics of Man. Those people are dead, but the images look like they were drawn yesterday. We still use those. Amalya’s images will live on long after you and I are gone.
&
nbsp; “There’s a Latin phrase I learned in my training: Mortui vivos docent. It means ‘The dead will teach the living.’ But that’s not true. In emergency medicine, people die all the time, and we fail exactly the way we failed before. Because there is a shortage of donors worldwide, we don’t learn how to do a thing differently,” Scotty said.
“It is one of the greatest wastes on the face of the earth.”
CHAPTER ELEVEN
The Dance
2013–14
It had been nearly four years since Thomas’s donation, and it was becoming clear there were more chapters yet to unfold.
In November 2013, Dr. Zieske from Schepens surprised us with an incredible gift: a copy of a study that may have been a result of Thomas’s donated corneas. “Potential of Human Umbilical Cord Blood Mesenchymal Stem Cells to Heal Damaged Corneal Endothelium,” published in the journal Molecular Vision on March 2, 2012, was very likely based on Thomas’s donation. We couldn’t know for sure because of confidentiality issues, but it could be a written record of Thomas’s contribution to the advancement of medical science. It contained beautiful images of what were possibly Thomas’s eye cells.
And the study itself was even more interesting.
The cornea is the clear outer layer of the eyeball, sort of like the eye’s windshield, and it looks like a transparent contact lens. Endothelial cells in the cornea do not regenerate, so if a cornea gets damaged, it stays damaged. Also, corneas naturally get worse as we get older. A newborn baby has all the corneal cells the person will ever have, and we lose about 10 percent of them every decade. In addition to normal wear and tear, some genetic diseases lead to vision impairment. One in particular is Fuchs’s endothelial dystrophy. According to the National Institutes of Health (NIH), Fuchs’s is a disease of middle age, affecting approximately 4 percent of people over age forty, with women being affected more often than men. In its milder forms, patients don’t necessarily notice a change; in advanced cases, patients experience vision loss.
