Designer pioneers new sockets for patients

For artificial limbs: Through exclusive arrangement, Manchester practice puts advances in prosthetics to the test.

By DENIS PAISTE
New Hampshire Union Leader

MANCHESTER - Next Step Orthotics and Prosthetics Inc. and Biodesigns
are pioneering a new design in attaching artificial limbs that transforms patients' lives.

The patent-pending High Fidelity interface, or socket, from Santa Monica, Calif.-based Biodesigns Inc., is being used by fewer than 100 amputees nationally but has significant potential for growth.

"The socket change has ... changed my life, because I can actually wear the prosthetic for more than an hour before I need to take it off, for obvious reasons, for perspiration and discomfort," said Charles W. "Chuck" Hildreth, 47, of Gilford.

"Normally, it's eight to 10 hours a day that I wear it," he said. "That gets me through the day and till I want to relax at home and just watch TV."

The breakthrough is in the attachment to an amputee's limb. Biodesigns says the carbon fiber laminated tube that makes up the socket has open areas to allow pressure from a limb's tissue to release, while maintaining compression to strengthen the overall fit and "lock" a bone in place. Other designs, the company says, allows bones to move too much. The socket, or tube, can be solid or opened up for additional comfort and suspension.

DEKA's interested

On a recent visit to Manchester, Randy Alley, CEO and chief prosthetist of Biodesigns, said the Santa Monica firm is deliberately moving slowly on expanding.

Biodesigns has about 40 lowerlimb patients and 30 upper-limb patients through Alley's practice on the West Coast, and about a dozen are being helped through Next Step in Manchester.

"The tagline I use is that the traditional designs, they tend to absorb motion whereas the High Fidelity design captures motion," Alley said.

The Biodesign interface is also the foundation for the "Luke arm" interface being developed for the military by Dean Kamen's DEKA Research and Development Corp. in the Amoskeag Millyard, and Hildreth was one of the first to take part in testing.

Hildreth also was the first patient at Next Step to be fitted with a High Fidelity interface. "It brought prosthetic fitting out of the dark ages," he said.

Matthew J. Albuquerque, Next Step's chief prosthetist and vice president, said, "The benefit from Randy's design ... is it only contacts the person where it needs to contact them and has reliefs everywhere else."

For now, Next Step is the only firm licensed to use the High Fidelity interface.

"We're looking at expanding that, but I'm going to be very selective," Alley said. "Matt is a great guy, incredible prosthetist, and he cares about his patients. That's the criteria that you have to have before you're going to be able to use this interface."

Exceeded expectations

While he thought the theory for his design was workable, "It worked beyond our wildest imagination," Alley said.

"We look at blood profusion and we make sure there is adequate circulation," he said.

"It's amazing that the body tends to regulate over time to actually force more blood through, so it's pretty neat to find that out," Alley said.

"What's nice about this is that it actually feels more comfortable to them, even though it looks more severe," he said.

Wearers say their prostheses feel more like a part of them and feel lighter, too.

Hildreth said the stability and comfort he feels "is something that I never thought in 100 years I'd be able to achieve with what we were using in the past.

"When this design came out, it was just a tremendous relief," he said.

Quality of life

Hildreth, 47, lost both his arms in an electrical accident in 1981, except for a stub of his less-damaged left arm. He also lost two-thirds of his left knee and three toes off each foot as a result of the accident.

Hildreth drives with his feet using a specially adapted vehicle.

Before the new interface, "the only time that I ever wore my prosthetic arm was to eat dinner," he said.

"This one I can put on in the morning, have lunch, go through the rest of the day, have dinner, help cook dinner, you know, it's that benefit to quality of life that I hadn't been able to have until this socket," Hildreth said.

Prosthetist Albuquerque said, "Every person is different. That customization is where we come in, that's our expertise.

"This design really allows you the customization person-to-person, which is about as different as you could imagine," he said.

"The biomechanical concept hasn't changed since day one," Alley said. "That's the beauty of it.

"It's how it's exactly applied to that particular person that we're always tailoring," he said.

Business model

Insurance pays for most interface designs, Alley said, based on individual determinations.

"We hope we get that patent, but that's not going to stop the idea that we can create an entire business around the interface itself," Alley said.

"There are some business models we are looking at in terms of creating centers that offer just the interface design," he said. "The main concern is safety for the patient. We go through a lot of checks and balances.

"Part of the idea is to roll this out so that both Next Step and Biodesigns have a lot of patients coming to us and we'd fit them with the High Fidelity interface," Alley said.

Alley has trained Albuquerque over the last 2 1/2 years. "It is very complicated and complex in terms of the amount of time that I need to get a good result, which is sometimes the limiting factor," Albuquerque said.

Other impacts

Because Hildreth can do so much more, Albuquerque said, "His wife is finding a whole new list of honey-do projects for him that never existed before.

"But what a great benefit for her ... to have somebody that she knows not only feels good about what he does but what he can do for everyone else in the family," he said.

Besides his wife, Donna, Hildreth's family includes a son, Collin, 14, and daughter Bailey, soon to be 11.

"One of the things that you see is my kids, when I'm using the arm, they look and you can see the expressions on their face, that they're happy, you can tell," Hildreth said.

Hildreth has addressed his son's classes. In second grade, "I went in to talk to the classroom, and amazingly, none of them had questions. I think it was fifth grade where they were doing a (unit) on how to overcome obstacles in life in their social studies, so I went in and talked to the group about it."

"When you think things are down (you) can always find a bright side," he said.

Albuquerque said the benefits of the High Fidelity interface are not just for the individual and his family, but society as well. "He walks in as a wonderful human being, confident in himself, and what he does.

"And married with children, here's this guy living life to the fullest, it is such a great example of what technology does, not only for him, but the rest of us," Albuquerque said.

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