Biomet Breaking New Ground

July 28, 2016 at 4:25 p.m.

By Laurie Hahn, Times-Union Staff Writer-

Two previously conjoined twins may have a chance at living normal lives, thanks to the efforts of one of Warsaw's orthopedic companies.

Biomet Inc. is joining with Dr. Ken Salyer, who headed the medical team that separated 18-month-old Egyptian twins Ahmed and Muhammed Ibrahim last month, to invent a covering for the boys' skulls. At a press conference Tuesday at Biomet corporate headquarters, Salyer said that while the ultimate solution has not yet been devised, "we're very impressed here with the talent at Biomet ... and we look forward to coming up with the optimum solution for these boys."

Salyer, the founding chairman of the World Craniofacial Foundation, said the next step is for the boys to completely recover from their separation surgery, which he hopes will be in a matter of months. Then they will be ready for their next surgery, which should be one of only two or three procedures expected for each boy.

The plan, and the challenge, according to Biomet engineer Joel Higgins, is to come up with a material that can stimulate bone growth as the boys grow.

"This situation creates very challenging aspects because not only do we want to try to regenerate bone, but with the risks involved, we want to use a minimal amount of foreign material associated with it as well," he said.

The idea so far, Higgins said, is to isolate growth factors from the boys' blood and add those to various materials that would be placed on a "scaffold," a resorbable polymer that will gradually be absorbed by their bodies as the bone material grows.

"By doing that, we can literally accelerate the normal healing response, and what will occur is improved vascularity in the area ...," he said.

Dane Miller, president and CEO of Biomet, said, "Basically, we're talking about using the children's own tissue as well as cadaver tissues, processed in some fashion, that will allow growth to take place. The initial step will be to design something that is temporary in nature and that can expand the skin for the final implants."

Biomet engineer John White used a model of the boys' skulls to demonstrate their condition now and what the team hopes to accomplish. He said the doctors have not yet decided whether they want a one-piece or a four-piece skull implant, but they are trying to take the basic shape of the tops of the boys' heads and "break it up into different components in order to allow some adjustability in this skull cap."

One prototype developed in the past few days involves a "sort of main strut that would go from one side of the skull to the other, and this component may or may not have a junction in the middle which could allow some adjustability for the implant to be adapted to the children's skulls. ... And then we're also looking at adding some additional components on the sides that would allow some adjustability of the skull cap to allow protection ...," White said.

The skull and brain, Salyer said, grow 2-1/2 times from the time of birth up to 18 months, "so the boys have already passed that peak point of growth, so in the future ... we would expect very little change of growth in terms of the actual growth of what's here. There's going to be some gradual (growth), but the main growth has already occurred."

To protect the boys' brains until implants can be designed, said Dr. Raul Barcello, a member of the surgical team, before the separation surgery, doctors expanded tissue from the boys' thighs to create patches of tissue that was used as graft over the brains. On top of the grafts, doctors expanded skin from the boys' scalps over a three- or four-month period before surgery, and that skin formed "flaps" that covered the whole area of the surgery after the separation.

In addition, the boys are wearing helmets for more protection.

Salyer said the uses for whatever material is devised can go far beyond the Ibrahim twins.

"One in 500 births in the U.S. have cranial deficiencies," he said. "Ultimately there may or may not be enough bone. ... So finding a source of bone is a major deal for us."

"It probably goes without saying that we're breaking new ground here," Miller said.

Salyer added: "All of this that we're talking about is taking the best of what's available, the state of the art, and combining it to create what we think will be the best for these two children." [[In-content Ad]]

Two previously conjoined twins may have a chance at living normal lives, thanks to the efforts of one of Warsaw's orthopedic companies.

Biomet Inc. is joining with Dr. Ken Salyer, who headed the medical team that separated 18-month-old Egyptian twins Ahmed and Muhammed Ibrahim last month, to invent a covering for the boys' skulls. At a press conference Tuesday at Biomet corporate headquarters, Salyer said that while the ultimate solution has not yet been devised, "we're very impressed here with the talent at Biomet ... and we look forward to coming up with the optimum solution for these boys."

Salyer, the founding chairman of the World Craniofacial Foundation, said the next step is for the boys to completely recover from their separation surgery, which he hopes will be in a matter of months. Then they will be ready for their next surgery, which should be one of only two or three procedures expected for each boy.

The plan, and the challenge, according to Biomet engineer Joel Higgins, is to come up with a material that can stimulate bone growth as the boys grow.

"This situation creates very challenging aspects because not only do we want to try to regenerate bone, but with the risks involved, we want to use a minimal amount of foreign material associated with it as well," he said.

The idea so far, Higgins said, is to isolate growth factors from the boys' blood and add those to various materials that would be placed on a "scaffold," a resorbable polymer that will gradually be absorbed by their bodies as the bone material grows.

"By doing that, we can literally accelerate the normal healing response, and what will occur is improved vascularity in the area ...," he said.

Dane Miller, president and CEO of Biomet, said, "Basically, we're talking about using the children's own tissue as well as cadaver tissues, processed in some fashion, that will allow growth to take place. The initial step will be to design something that is temporary in nature and that can expand the skin for the final implants."

Biomet engineer John White used a model of the boys' skulls to demonstrate their condition now and what the team hopes to accomplish. He said the doctors have not yet decided whether they want a one-piece or a four-piece skull implant, but they are trying to take the basic shape of the tops of the boys' heads and "break it up into different components in order to allow some adjustability in this skull cap."

One prototype developed in the past few days involves a "sort of main strut that would go from one side of the skull to the other, and this component may or may not have a junction in the middle which could allow some adjustability for the implant to be adapted to the children's skulls. ... And then we're also looking at adding some additional components on the sides that would allow some adjustability of the skull cap to allow protection ...," White said.

The skull and brain, Salyer said, grow 2-1/2 times from the time of birth up to 18 months, "so the boys have already passed that peak point of growth, so in the future ... we would expect very little change of growth in terms of the actual growth of what's here. There's going to be some gradual (growth), but the main growth has already occurred."

To protect the boys' brains until implants can be designed, said Dr. Raul Barcello, a member of the surgical team, before the separation surgery, doctors expanded tissue from the boys' thighs to create patches of tissue that was used as graft over the brains. On top of the grafts, doctors expanded skin from the boys' scalps over a three- or four-month period before surgery, and that skin formed "flaps" that covered the whole area of the surgery after the separation.

In addition, the boys are wearing helmets for more protection.

Salyer said the uses for whatever material is devised can go far beyond the Ibrahim twins.

"One in 500 births in the U.S. have cranial deficiencies," he said. "Ultimately there may or may not be enough bone. ... So finding a source of bone is a major deal for us."

"It probably goes without saying that we're breaking new ground here," Miller said.

Salyer added: "All of this that we're talking about is taking the best of what's available, the state of the art, and combining it to create what we think will be the best for these two children." [[In-content Ad]]

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