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Sep 21
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biodesigns Awarded $1.5M Phase II and Option SBIR DARPA Contract

By Prosthetics, Upper Extremity

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

 

Sep 18
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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 the main focus is on everything else but the core problem that affects you the most: your socket, or as we prefer to call it, your interface.

It’s common to hear prosthetists say 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 what’s attached rather than how it’s attached, who do you think suffers?

At biodesigns, the interface is everything to us. Sure we provide the latest in cutting edge technology, and are experts in optimizing components, but 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 isn’t the challenge. Having it stay on and be comfortable should be a given, not some “great achievement.”

The truly serious challenges lay beyond simple comfort and suspension. Our focus is in extracting every ounce of effort you put in to the interface and transferring it to the rest of the system. Our goal is to make you one with your prosthesis, 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. Do you think we arrived at that name by accident? Fidelity: the degree to which a copy of something mimics the true character of the original. 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 biodesigns is – and will always be – a “NO BUCKET ZONE.”

–Randall Alley, CEO, biodesigns, inc.

May 22
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Back on the Ice: Innovative Socket Gets Arm Amputee Playing Hockey

By Biodesigns, HiFi, Press Release / Media, Prosthetics, Socket Technology, Upper Extremity
WESTLAKE VILLAGE, CA – After nearly 30 years away from his passion, Andrew Carter has returned to ice hockey. The long-absence from the game wasn’t self-imposed for the 48-year-old. “I grew up playing on the street and organized leagues on ice until I was 14 when I lost my hand and wrist in an electrical accident,” he said. Fast forward from 1984 to 2013 and Carter found a way to get back on the ice through a prosthetic attachment that enables him to control the hockey stick, coupled with an innovative socket system that keeps his prosthesis not only snug and secure, but radically alters the way he plays his game — the HiFi™ Interface System created by Randall Alley, CEO and chief prosthetist of biodesigns inc., a prosthetic clinic and R&D facility.
“I was physically active all my life but I didn’t realize there were prosthetics that would stay on and perform in the way that the HiFi system does and also the hockey specific attachment made by Bob Rodocy from TRS Inc.,” Carter said. It was Radocy, who is also an arm amputee, who referred Carter to Alley, who is known for his extensive experience in upper-limb prosthetics and his commitment to superior biomechanics. Alley previously fit Radocy in a HiFi socket he uses for swimming and scuba.  With the HiFi, Carter was able to return to the ice for the first time since he was a teenager. “The HiFi makes me a much better player. It enables me to go out there and be competitive because of the way it perfectly captures every motion of my arm,” Carter said. Unlike most upper-extremity prostheses for heavy physical activity, this one does not have a series of straps and shoulder harnesses to hold it on. The four internal compression areas of the socket control the shaft of the underlying bone by gently displacing some soft tissue out of the way, causing the remaining soft tissue surrounding the bone to become denser.
“At a glance, it might look uncomfortable,” Carter said, “but it actually isn’t. There is virtually no movement inside the actual prosthesis. The usual give and take of soft tissue movements inside a normal prosthetic shell is completely gone, and that translates into a substantial increase in both power and accuracy. This is great for me and probably not so good for opposing goaltenders.” Carter’s return to the ice came after months of relearning how to stick handle, pass and shoot, practicing on dry land. “What the HiFi and TRS’s terminal device enabled me to do is to be able to get back out there and play. I don’t really think of it as a prosthesis; it’s an extension of me,” he said. Carter joined the Ice Angeles 8-Bits adult hockey team in 2014 and was instrumental as the 8-Bits swept the finals to become league champions in 2017. “Hockey has been my favorite sport for a long time so it’s been a really big deal for me to come back and play on the team and be in the locker room with my teammates,” he said.
Besides hockey playing, Carter is a regular at the gym, but found difficulty in holding weights and doing upper body exercises. “It’s very difficult with one hand to load your body evenly and do a great deal of upper body exercises, so I invented a device called the Carter Cuff to help me and other amputees or persons whose hand function is temporarily or permanently impaired. The Carter Cuff is an armband, which includes a number of reinforced D-Rings providing connection to exercise machines and free weights. An optional shoulder harness can be attached to the armband for additional stability. It allows the user with a disability to perform numerous exercises that would otherwise by impossible. The user can row, press, pull down, press down, curl, chop and perform suspension, barbell, dumbbell and kettle bell work, all while loading the body evenly.
“It’s become this really special second life that I couldn’t envision. I’m lucky to be in a position where I can do this. I’m lucky that I got referred to Randy by Bob. I got VIP treatment from the day I walked in there. Randy has been nothing but amazing!”

Learn more about the Carter Cuff. Click here.
Nov 14
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By Biodesigns, HiFi, Prosthetics, Socket Technology, Upper Extremity

Prosthetic sockets stabilized by alternating areas of tissue compression and release

Randall D. Alley, CP; T. Walley Williams III, MA; Matthew J. Albuquerque, CPO; David E. Altobelli, MD

biodesigns Inc, Westlake Village, CA; Liberating Technologies Inc, Holliston, MA; Next Step Orthotics & Prosthetics Inc, Manchester, NH; DEKA Research and Development Corp, Manchester, NH

INTRODUCTION

Traditional upper-limb prosthetic sockets share certain problems. Most sockets simply contain the tissue of the remaining limb. Since a prosthetist produces them by slightly modifying casts taken by wrapping plaster bandages around the limb, the sockets are usually circular in cross section and thus encapsulate the limb. The advent of myoelectric control led to new socket designs. Transradial (TR) sockets were needed that would stabilize the location of the electrodes, and the Muenster and Northwestern sockets were introduced. These sockets are self- suspending but nonetheless still display a number of problems. They do not permit the user to fully flex or extend the elbow, they do not prevent lost motion between the bones of the remaining limb and the distal prosthetic structure during active lifting, and they do not load the bone uniformly but rather concentrate the load near the ends.

Myoelectric control also changed transhumeral (TH) sockets with the introduction of the Dynamic Socket. It has a low lateral trim line to prevent the lifting of the electrodes during the extremes of flexion and abduction. It also has anterior and posterior wings that stabilize the prosthesis against rotation around the long axis. Similarly, the X-frame socket has replaced the full con- tact socket for amputations at the shoulder level, because it permits the user to bend forward and to move the shoulder while maintaining good contact with electrodes. It also stabilizes the prosthesis against rotation at its superior and inferior borders and covers far less surface area of the thorax for increased heat dissipation. In this article, we review the evolution of these designs with additional references by Lake.

LONGITUDINAL DEPRESSIONS AND RELEASE AREAS DEFINE COMPRESSION/RELEASE STABILIZED SOCKET

This article will introduce improved sockets for persons with TR, TH, and transfemoral (TF) amputations created with longitudinal depressions added in the socket walls with open release areas between the depressions that receive the displaced tissue. When the depressions and release areas are correctly located, they reduce motion of the underlying bony structures with respect to both the socket and the rest of the prosthesis. One can define the depressions and releases during cast-taking but only by radically changing the way casts are taken.

Traditionally, the prosthetist uses a plaster wrap to define the shape of the remaining limb. The typical plaster wrap results in a shell that is almost circular in cross section throughout most of its length. When the shell is filled with plaster, the prosthetist modifies the resulting positive model before creating a socket over it by laminating or by thermoforming plastic. The prosthetist then adds extra plaster to the model to create space in the socket to accommodate bony prominences and removes the plaster to tighten up the fit. The experienced prosthetist can speed up the rectification process by contouring the original cast while it is setting.

Creating a compression/release stabilized (CRS) socket requires one to apply selective pressure during cast-taking, but this pressure must be applied in a specific way. A definition of terms will help the reader to follow the discussion. We only briefly summarize the casting process here, because prosthetists must be fully trained and certified in the application of this design such that patients are not harmed because of an incomplete understanding of the process.

If during the cast-taking, the technician pushes inward toward the bone, he or she will create a depression in the resulting cast. When the depressed area is parallel to the length of the underlying bone, it will appear as a channel or longitudinal depression. Further use of the word depression in this article will describe any shape created by pushing inward and use of longitudinal depression will describe long depressions parallel to the bones underneath. If one pushes a substantial area inward while holding the limb of the amputee, this action will displace tissue in other areas outward to form bulges. When the cast is taken, the stretched plaster wrap over these bulges still applies some inward force. For a CRS socket to perform correctly, these areas should have little or no inward force where the tis- sues bulge. After all remaining force is removed between the longitudinal depressions, the areas between are called release areas. After we discuss the physics underlying the operation of a CRS socket in this article, we will briefly illustrate how each of the three socket designs (TH, TF, and TR) can be created using the plaster cast technique. The unique features of these sockets are the longitudinal depressions and the release areas. The release areas are critical to the functioning of this new socket design.

 

For the full article, click here https://www.rehab.research.va.gov/jour/11/486/alley486.html

 

 

 

Oct 09
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biodesigns Delivers World’s Most Advanced Arm During CA Fires

By Press Release / Media, Upper Extremity

WESTLAKE VILLAGE, Calif., Nov. 15, 2018 — biodesigns, inc., Southern California, delivers the “Luke Arm” to amputee during the recent fires that hit Westlake Village.

Amidst the fires and evacuations that recently hit Westlake Village and surrounding areas, amputee Brian Roberson is one of a few individuals to receive the world’s most advanced upper limb prosthetic system – the modular, bionic Luke Arm and X-Frame Interface.

The Luke Arm, manufactured and distributed by Mobius Bionics LLC of New Hampshire, provides advanced features and capabilities including state-of-the-art flexibility, strength and dexterity. The Luke Arm is the result of 10 years of development by a team led by Dean Kamen’s company DEKA Research & Development, as part of DARPA’s (Defense Advanced Research Projects Agency) Revolutionizing Prosthetics Program (RP2007).

Randall Alley, CEO and Chief Prosthetist for biodesigns, Westlake Village, was a primary interface (socket) consultant previously engaged by DEKA on the Luke Arm RP2007 project to assist with the user attachment strategy. Alley, knowing traditional socket approaches would yield inferior results and arm rejections, brought his innovative High-Fidelity and X-Frame interface designs to the program. His success with the Luke Arm system eventually led biodesigns to their own DARPA SBIR contract and now biodesigns is one of a few companies in the world authorized to fit this advanced bionic arm.

“At biodesigns we have an intense focus on socket/interface biomechanics and how it relates to user acceptance and user performance with their prosthetic system(s). While the prosthetic industry has seen incredible advancements in components, it has not only lacked progress in socket technology, it has all but ignored the critical role of the interface in ensuring wearer success. The sockets being used by most prosthetists today are decades old and have been plagued with numerous issues. As the components become more advanced, the interface or connection platform becomes vitally important. Our goal is to continue to develop innovative, non-surgical attachment approaches focused on achieving superior user comfort, stability, connectivity, and the ultimate goal – device embodiment,” stated Alley.

Brian, who is currently living out-of-state, traveled to biodesigns in CA due to their unique interface expertise, experience and success fitting this advanced arm system.

“I have experienced a lot these last few days but am very happy to be back at biodesigns office practicing with this new arm,” stated Brian Roberson.  As a machinist, this new arm will allow me to go back to work and help me regain my life back.”

About biodesigns inc.

Southern California-based biodesigns, inc. is a technology-driven prosthetics company specializing in the most advanced patient care, research and product development for individuals who have experienced upper and lower limb loss. The company’s approach utilizes innovative clinical techniques and the most biomechanically advanced prosthetic interface systems available, including the High-Fidelity Interface and Imager System. biodesigns works with upper and lower limb wearers of all ages and activity levels, but also provides interface/socket trainings and licensing to other prosthetists as well as consulting services in and outside the field of prosthetics.

May 20
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The Effect of Transfemoral Interface Design On Gait Speed and Risk of Falls

By HiFi, Knee Technology, Lower Extremity, Prosthetics, Socket Technology

 
By: Jason T. Kahle, Tyler D. Klenow, William J. Sampson, M. Jason Highsmith

September 2016, Technology and Innovations, Vol. 18, pgs. 167-173, The Effect of Transfemoral Interface Design On Gait Speed and Risk of Falls

The purpose of this study was to compare the effect of TFA interface design on walking capacity and balance confidence A retrospective cohort design was utilized involving unilateral TFA patients who used ischial ramus containment (IRC) and High-Fidelity (HiFi) interfaces. Falls and diminished walking capacity are impairments common in persons with transfemoral amputation (TFA). Reducing falls and optimizing walking capacity through such means as achieving a more normal gait speed and community ambulation should be considered when formulating the prosthetic prescription. Because walking capacity and balance confidence are compromised with TFA, these outcomes should be considered when evaluating interfaces for transfemoral prosthetic users. The purpose of this study was to compare the effect of TFA interface design on walking capacity and balance confidence A retrospective cohort design was utilized involving unilateral TFA patients who used ischial ramus containment (IRC) and High-Fidelity (HiFi) interfaces (independent variables). Dependent variables included the Activity-specific Balance Scale (ABC) and the two-minute walk test (2MWT). Complete records were available for 13 patients (n = 13). The age range was 26 to 58 years. Three patients functioned at the K4 activity level, whereas all others functioned at the K3 level. Mean ABC scores were significantly different (p ≤ 0.05) at 77.2 (±16.8; 35.6 to 96.9) for IRC and 90.7 (±5.7;77.5 to 98.7) for HiFi. The mean distance walked on the 2MWT was 91.8 m (±22.0, 58.3 to 124.7) for IRC compared to 110.4 m (±28.7; 64.7 to 171.1) for the HiFi socket (p ≤ 0.05). Alternative transfemoral interface design, such as the HiFi socket, can improve walking capacity and balance confidence in higher-functioning TFA patients.

Read Full Article Here

 

May 18
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Quadruple Amputee Lives Life To The Fullest

By Biodesigns, HiFi, Socket Technology, Upper Extremity

Aimee Copeland Describes Her HiFi’s

“I was in traditional sockets previous to the HiFi and they felt bulky, loose and heavy. In my new HiFi, my prostheses feel connected to me, like they are a part of my body,” Aimee said. “They feel lighter, more comfortable, secure, and I forget they are there.”
Download Full Release Here

Julie Alley, President, Chief Marketing Officer

Jalley@biodesigns.com

o/c: 310-717-1024

Randall Alley and The High-Fidelity Interface System have been featured in national media. Contact us to learn more.

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