by Deborah Conn

Innovation is thriving in O&P. Last year’s article on O&P inventors (see September 2006, "O&P Inventors: Bringing Bright Ideas to Market") spurred others to write in about their continuous quest for creative solutions, ranging from more efficient fabrication tools to improved O&P devices. And for every invention that is on its way to market, there are dozens more on the drawing board, or in fabrication, or being used in a particular practice, or in someone’s imagination. 

The six inventors profiled here offer a glimpse into the creative minds that invigorate our profession. Several began as practitioners who so loved the problem-solving process, they established their own research and development companies. 

From one patient to many
One of these is Randy Alley, CP, LP, FAAOP, CFT. Alley began his Los Angeles-based research and development company, Biodesigns Inc., in 2000. At the time, he was still working for the Hanger Orthopedic Group, where he headed the national Upper Extremity Prosthetic Program. 

As an upper-limb specialist and director of the program, Alley worked with O&P practitioners throughout the country. But he wanted to do more. “We were working on one patient at a time,” he says. “My goal was to reach as many people as possible at the same time.” 

He appears to have realized that desire with the inventions he markets. For instance, he has just sold the rights to a pair of auto-expulsion valves, the PushValve and MagValve, to Otto Bock Healthcare.

“The difference with these valves is that they are threadless,” says Alley. “Nearly all others, with the exception of a few specialized applications, are screwed in. They are hard to twist and often require a special tool to loosen them. They pull hairs and can be difficult to work with. A bilateral amputee wouldn’t be able to manage turning these screws easily, and it would be difficult for any amputee with hand involvement.” Alley conceived and co-developed this threadless design for the valves, vastly simplifying the patient’s process.

Another Alley invention on the market today is the BAHA, or Biomechanically Aligned Harness Anchor, developed with Bob Radocy of TRS Inc. in Boulder, Colo. The BAHA is a non-metallic upper-limb harness system that reduces stress on the axilla while simultaneously increasing control and energy efficiency. Alley devised a vertical dual-ring design that Radocy then refined and produced in a special polymer. 

Still another project is in field trials. Radocy approached Alley to help develop a system that would improve the control of cable-operated prostheses. Most upper-limb amputees use a “voluntary opening” device, which must be opened by the wearer but closes on its own. But voluntary opening devices typically limit the weight and size of objects that can be grasped to small, lightweight household items. A “voluntary closing” device can provide more pinch force, but the wearer must exert constant tension in order to maintain it.

Alley, Radocy, and engineer Brad Veatch of ADA Technologies in Littleton, Colo., decided to work together to devise a system for both voluntary closing and voluntary opening devices. 

Named the Sure-Lok, the product uses a cable locking mechanism that allows voluntary closing users to hold an object without exerting continuous tension, while permitting voluntary opening users to grasp delicate items more easily. “Our first version utilizes a manual lock,” says Alley, “but future versions will be alternatively controlled.”

Creating innovation for others
Jay Martin, CP, LP is someone else who moved from clinician to inventor. As a practitioner with the Scott Sabolich Prosthetics and Research Center in Oklahoma City for seven years, Martin came up with several innovative designs that improved his patients’ ability to function. “I realized there was a lack of available technology to help my patients function [at] their full potential,” he says, “so I set out to change that.”

In 2002, he established Martin Bionics in the same city. At first, he was a one-man operation, teaching himself how to write grant proposals and patent applications. “I was fortunate enough to win a few large research grants and have had several patents approved,” he says. “Now we have a full engineering service and innovation company with a team of 10 hand-selected engineers on staff.” 

The company has eight commercially available products, most through licensing arrangements with other prosthetic manufacturers. “That’s our model,” explains Martin. “We’re very good at coming up with high-tech innovations, translating them into practical designs, and then bringing them to market through licensing to major manufacturers.”

One of Martin’s early designs was a novel socket for hip-level amputees. Martin came up with the design one morning in the shower, arrived in the office, modeled the design into a prototype and fit it on a patient who had been unable to use a conventional socket and hadn’t walked in 17 years. It worked. 

“Our approach uses a different method of contouring structural components around the underlying anatomy,” says Martin. “Our socket is half the size and half the weight of conventional hip-level sockets and offers a greater range of motion and increased stability for the user.” 

Soon to be commercially released is a computer-controlled ankle joint. “This prosthesis can think, respond, and react to environmental changes,” he says. “It has its own internal prosthetic brain and provides full accommodation for force, speed, and terrain changes for ambulating in the ‘real-world’ environment. Unlike existing devices, it mimics the full biomechanical function of ambulation.” Martin licensed the ankle technology to College Park Industries, which will have global rights to market, manufacture, and distribute the technology. 

Martin’s company is highly involved with the integration of nanotechnology in O&P. “One of our current projects involves superhydrophobic nanotechnology,” he says, “which alters the surface structure of a material on a nano scale so that it becomes super-water-repellant. A drop of water can hit this surface and literally bounce up and down instead of clinging to it through surface tension. 

“As this technology is integrated into O&P devices, they will be far more hygienic. For example, the typical socket or liner gets saturated with body fluids and begins to smell over time. With this technology, fluids would simply roll off.” 

Martin hopes to have this technology ready for licensing and implemented into the field in the next 12 to 18 months. 

Thanks to projects like these, Martin knows he made the right career move. “I feel this is what I was created to do,” he says. “I knew I wanted to have an effect on people’s lives. Creating innovations is how I do it.” 

A cool idea
Steven Thomsen, CP, had an idea for a cool invention—literally. "It came to me while I was on a long bike ride,” he recalls. “I was dripping sweat, but my feet were nice and cool.”

Wondering why his feet felt so good, Thomsen realized that his moisture-wicking socks and mesh shoes allowed for evaporation with the movement of air through the shoes. Then it occurred to him that he could apply the same concept to prosthetic sockets. Seventy miles later, Thomsen had figured out how to use nylon mesh material to ventilate a socket without compromising the intersocket pressure.

Heat and moisture inside of sockets has always been a problem. Nevertheless, until a few years ago, there was no published literature on the subject. Finally, in April 2005, the Journal of Rehabilitation Research and Development published a study by scientist Glenn Klute that measured socket temperatures. Thomsen called Klute, and the two collaborated on the project. 

Simply cutting a window in the socket for ventilation wouldn’t work, says Thomsen. “The limb would get window edema, which can become a big problem with skin integrity.” 

Thomsen’s solution was to cover the window with non-stretchable nylon mesh. “I found a medically approved acrylic adhesive that, once cured, bonds the mesh to the plastic of the laminated socket. It’s a beautiful, easy technique,” says Thomsen, “and I have preliminary data from IRB-approved research which shows a significant difference between the windowed and standard sockets.”

Thomsen, who works at the Shriners Hospital for Children in Springfield, Mass., realized that patenting his innovation was not the motivation for the research. “I don’t really call it an invention,” he says, “It’s just an idea we’ve put to use that can possibly make a more comfortable socket for the amputee.” 

“Glenn Klute and I have both given presentations on temperatures inside the socket. We have both found it very interesting to see how high these temperatures can go. With the information gathered from our various projects, we hope that the O&P community will realize more effort should be made to cool the sockets of amputees.” 

Thomsen’s interest in socket temperatures continues. He has enlisted Western New England College in Springfield to work on three other projects, including the horizontal and vertical wickability of various stump sock materials, the thermal conductivity of liners and other interface materials and the thermal conductivity of different socket materials.

A patented socket
Russell Burton, CPO, of Burton Prosthetics in Omaha, kept noticing a recurring problem in his practice: many of his below-knee amputation patients found it difficult to flex their knees while wearing their prostheses.

“Suction sockets and durable, flexible suction sleeves have increased the ability of amputees to be linked to their prostheses. The prosthesis feels like it’s part of their body [and] they love that—but then they can’t bend their knees,” he explains. 

Burton focused on figuring out how to increase his patients’ range of motion. “I was trying ways to capture the shape of the knee in the flexed and extended position, when all of a sudden it dawned on me that I just needed to start with the knee in the flexed position,” he says. 

“I make a rigid module out of synthetic casting tape [and] put it directly around the knee so that it extends an inch and a half above the patella and an inch below. Then the patient flexes his leg to 90 degrees, which gives me a distinct shape of the knee in the flexed position. I take off the module, trim it, cut it, and place it back on the leg. Then I cast the lower end with the leg at about 10 degrees of flexion and combine the two.” 

The result, says Burton, is a socket that allows users to go through the normal range of motion. “The shape of the socket is so much more anatomical,” he says. 

Burton’s invention recently received a patent, the first BK socket, he believes, ever to do so. The entire process, from design to patent, took about three years and cost just under $10,000. “That framed patent is the most expensive piece of art in my office,” he jokes. 

Burton has been using his as-yet-unnamed socket regularly for the past few years. “It’s not a panacea,” he cautions. “I make no claim that this is some sort of magic bullet, and it doesn’t work for every patient. It’s just something else I can use that works.” 

Burton is hopeful he will be able to market his invention to a large manufacturer, someone with the resources to put it to use on a widespread basis. In the meantime, his own patients are benefiting, and, he says, “I have something on my wall I can show my grandchildren.” 

Simple solutions
Many inventions stem from the universal quest for the easiest way to accomplish something. Sometimes the answer is surprisingly simple. 

As president of Freedom Fabrication Orthotic Laboratory Services in Havana, Fla., Tony Wickman, RTPO, often found himself using a hand file, tediously smoothing the surfaces of orthotic casts. “The file looks like a cheese grater,” Tony explains. “You hold on at each end and use human force to push it back and forth. It can be time-consuming and strenuous.” 

About five years ago, Wickman decided there had to be a better way. “One of the cool things about this business is that we have a whole tool shop,” he says, “so we can build and refine our prototypes in-house.” In this case, Tony took a commercially available file and simply added a motor. “Now I can just press a button, and the file does the moving back and forth.” 

The PowerFile has been patented, and Wickman is seeking a licensing partner. 

Seeds of invention: starting small
Often, the catalyst behind an invention in O&P is a patient with unusual needs that can’t be met with conventional products. The resulting device probably won’t get patented or perhaps even used for anyone else, but the impact it has on that one patient is profound. 

Such was the case with Bobby Johnson, OT, who works with cancer rehabilitation patients at the Virginia Commonwealth Medical Center in Richmond, Va. 

One of Johnson’s patients was a young woman who had undergone surgery that removed the upper portion of her sternum, both clavicles, and the first and second ribs on each side. She desperately needed chest protection but, says Johnson, the only product even close to fitting the bill was a TLSO.

Johnson had an idea for a chest shield and enlisted the help of Terif Zaki, BOCO, an orthotist with Virginia Orthotics and Prosthetics in Richmond, who devised a template of what Johnson had in mind.

Using the template, Johnson then created another shield out of orthoplast that he customized to the patient’s body. Gilberto Mejia, CP, with Hanger P&O Inc., in Richmond, helped fabricate a harness system.

In addition to the rigid shield, the patient needed a figure-eight clavicle sling that she could tolerate wearing and provided some protection. Again, Johnson came up with a new design, adding a foam pad that shielded her heart and lungs. 

Both devices have been successful. According to Johnson, the patient is at home and back to work now, wearing the figure-eight clavicle sling in the house, and the chest shield when she’s working and out in the community. 

Johnson’s creativity made a big difference in one patient’s life. Who knows? Perhaps he will come up with other ideas that reach a larger population. 

Innovation can start small. If you’re like most people in the O&P field, you’ve done your share of tinkering, modifying, and making improvements for special needs. Keep at it, and you may just turn out to be the brilliant mind behind the Next Big Thing. 

Deborah Conn is a freelance writer based in Falls Church, Va.