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September 2019

biodesigns Awarded $1.5M Phase II and Option SBIR DARPA Contract

By | Prosthetics, Upper Extremity | No Comments

WESTLAKE VILLAGE, Calif. – biodesigns, inc., Southern California, was awarded a $1.5M firm-fixed-price Phase II and Option Small Business Innovation Research (SBIR) Defense Advanced Research Projects Agency (DARPA) contract for the delivery of socket diagnostic tools for the manufacture and fitment of custom sockets for upper-limb prostheses.

Randall Alley, CEO and Chief Prosthetist for biodesigns, was a primary interface (socket) consultant for DEKA on their “LUKE” Arm, as part of DARPA’s Revolutionizing Prosthetics Program (RP2007), but this is biodesigns’ first DARPA contract.

DARPA’s call for the socket diagnostic tool innovation is a result of the challenges prosthetists face when designing the socket and suspension systems that hold prostheses on upper-limb amputees.

Variations among individuals introduce unique complexities that factor into fitting the socket, including muscle bundles, neuromas, bone spurs, skin conditions such as scars from burns and sores from infections and shear at the interfacial boundary.

As a result, the process of fitting sockets is currently a labor-intensive, manual approach. Current fitting techniques often yield sockets that are uncomfortable, unstable, or impede full range of motion, resulting in compromised device performance or election by the amputee to not use the prosthesis altogether.

To address these challenges, DARPA sought the development of innovative diagnostic tools to improve socket fittings and socket performance thus enabling prosthetists to more successfully and systematically deploy advanced upper extremity prosthetics, such as those developed by the DARPA RP programs.

The HiFi Interface™ and HiFi Imager™ System, created by Alley, is the platform technology for this contract and was also used in DEKA’s “Luke Arm” studies.

Intimate Connection to the Bone

The HiFi Interface with patented and patents-pending OsseoSynchronization™ technology is designed to replicate the stability achieved through direct connection to the bone that osseointegration surgery – the direct skeletal attachment of a prosthetic limb – provides. The HiFi is Alley’s non-invasive biomechanically-based socket solution that captures and controls the residual bone through an alternating compression and release design. “By displacing the soft tissue so there is less of a buffer between the bone and the interface wall in the compression zones, there is less unwanted motion of the bone. This reduced bone motion results in a much more dynamically responsive prosthesis that feels lighter, offers much greater stability and security, wastes less energy, and with the incredible proprioception it provides, patients also report feeling connected to their prosthesis,” Alley said.

A key to the success of Alley’s interface is his patented casting/scanning Imager which allows for the proper amount of compression in key areas but also allows patients the ability to provide feedback and help dictate their fit.

“We are excited and honored to be able to move forward with DARPA,” Alley said. “I have seen how our current HiFi system is already transforming amputees’ lives and we look forward to further advancements for our military and ultimately widespread use of this technology.”

Note: See the DEKA “LUKE” Arm in action with Alley’s X-Frame at www.youtube.com/biodesignsvideos

 

biodesigns Rejects Standard Of Care Sockets – So Should You

By | Biodesigns, HiFi, Press Release / Media, Prosthetics, Socket Technology

biodesigns declares they are a “bucket free” zone.

You see, we know something. And we think you know it too. Simply stated, there’s something just not right with the prosthetic industry. There’s something wrong when an entire field-from prosthetists to manufacturers, to therapists to doctors to the media and to just about everyone else who is in some way, shape or form involved in prosthetics-is focused on everything but the problem that affects you, the one who has to live with it, the most: your socket, or as we prefer to call it, your interface.
Sure you hear people say “oh, the socket is the most important part of a prosthesis.” Or, “the socket fit is everything.” Then how is it they continue to use interface designs that are decades old? Designs that pay little attention to biomechanical principles, that completely ignore the health of the wearer? You see, they can talk a good game all day long, but in the end, they’re focused on the components, the “sexy” stuff like microprocessor knees, powered ankles, or the latest electric hand. We get it, that’s all great gear, and it has its place. But guess what? With an entire industry enamored more with the attached accessories than the interface itself, what do you think suffers? Bingo!
At biodesigns, the interface is everything to us. Sure we provide the latest in cutting edge technology, and yes we’re probably more familiar with how to optimize manufacturer components than just about anyone else in the field. But tuning complex prosthetic systems is child’s play to us. Where we really dig deep is in the science of the interface. You see, we don’t describe our designs as merely “a good fit.” Making a tube or bucket “fit” your limb is no challenge. Having it stay on and be comfortable should be a given, not some great achievement. That’s like the prosthetist hitting the power button on your freshly delivered bionic leg and saying “yep, the light came on, I think we’re all goood.”
The serious challenges lay beyond simple comfort and suspension. Our focus is in extracting every ounce of effort you put in to the system and transferring it to the rest of the prosthesis. Our goal is to make you one with your entire system, so much so, you forget you are wearing it. This is embodiment. And to do this we have to rise above the incredibly low threshold of “yep, looks like a good fit!” or “gosh, it looks like it’s gonna stay on” and work on truly replacing what you lost. This means we have to mimic your actual skeletal motion, not absorb it in some loose fitting bucket. This means we have to encourage your neural network to start regrowing by fooling the brain into thinking your arm or leg is back. This means giving you a High-Fidelity Interface system. Do you think we arrived at that name by accident? Fidelity: the degree to which a copy of something shows the true character of the original. Cambridge dictionary. Isn’t that what you are looking for? To get as close as possible to what you lost? A bucket or a tube can’t do it. That’s why this is-and will always be a “NO BUCKET ZONE.”
Randall Alley, ceo, biodesigns, inc.