Randall Alley, HiFi Interface Inventor, is asking prosthetists to look to science not art when creating interface designs. It is well documented that current socket designs are plagued by inherent issues causing instability, rotational issues, pistoning, falls, skin issues, excessive energy expenditure, and the inability for wearers to sit up straight. Randall will be highlighting the research and benefits of his HiFi Interface System technology, including improved comfort, function, stability, faster walking speeds, improved gait symmetry and more. No more “buckets.” Time to step up to a better design. Time to step up for better science. Time to step up for our patients.
Captain Carey DuVal is an amazing example of someone who doesn’t let his amputation prevent him from achieving his goals. Captain DuVal is a transradial (below elbow) amputee as result of a VBIED attack during combat deployment to Afghanistan in 2014. Captain DuVal has utilized biodesigns’ HiFi upper limb prosthetic socket since 2015 as Active Duty Combat Arms Officer.
Captain DuVal is the first amputee of any kind to be selected at the U.S. Army Special Forces Assessment and Selection while utilizing a prosthesis. He is also the first amputee to attend the Special Forces Qualification Course. At the Q-Course, DuVal had to complete all the physical challenges of his fellow soldiers proving with the proper “equipment” (interface system), he could pass all the physical requirements. Captain DuVal credits the HiFi for allowing him to compete at his highest level. Congrats to Captain DuVal. You are a true hero.
biodesigns, in California, best known for their prosthetic interface/socket technology, recently delivered an advanced arm system during this unusual time as a result of the Corona Virus. “We consider our business vital to our patients and want them to know we are here for them,” stated Randall Alley, CEO, Chief Prosthetist for biodesigns. The system delivered included advanced technology including Alley’s patented and patents-pending HiFi interface design, Coapt Engineering’s Gen2 Pattern Recognition, College Park’s Espire Powered Elbow, and Motion Control’s Wrist Rotator and External Terminal Device (ETD2). The system will also be used with the user’s existing ilimb Quantum hand. biodesigns takes great pride in designing prosthetic systems that are appropriate for their users. “This user is long time wearer that has proven time and time again the many functional benefits he receives from his prostheses,” stated Alley.
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
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
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 plas- ter 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.
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.
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.”
Julie Alley, President, Chief Marketing Officer
Randall Alley and The High-Fidelity Interface System have been featured in national media. Contact us to learn more.
“There is definitely a preconceived notion that a body-powered system is lighter, but with this HiFi socket it makes the arm feel just as light as body-powered. There is more stability across the entire length of the arm. There are no pinch points, way more degrees of freedom, more responsive, better connection to all the sensors.”
“The HiFi has a lot more range of motion, which was critical for me. My other socket was useless and ended up in the cupboard. Sometimes I feel like my hand is back. I know bizarre…but my mind is being tricked.”
October 2016, The O&P Edge, Jonathan Cowley: Prosthesis Provides New Outlook, Hope
ABSTRACT. Traditional function and comfort assessment of transradial prostheses pay scant attention to prosthetic interface. With better understanding of the biomechanics of prosthetic interface comes better efficiency and safety for interface design; in this way, amputees are more likely to accept prosthetic usage. This review attempts to provide design and selection criteria of transradial interface for prosthetists and clinicians. Various transradial socket types in the literature were chronologically reviewed. Biomechanical discussion of transradial prosthetic interface design from an engineering point of view was also done. Suspension control, range of motion, stability, as well as comfort and safety of socket designs have been considered in varying degrees in the literature. The human–machine interface design should change from traditional “socket design” to new “interface design.” From anatomy and physiology to biomechanics of the transradial residual limb, the force and motion transfer, together with comfort and safety, are the two main aspects in prosthetic interface design. Load distribution and transmission should mainly rely on achieving additional skeletal control through targeted soft tissue relief. Biomechanics of the residual limb soft tissues should be studied to find the relationship between mechanical properties and the comfort and safety of soft tissues.
Randall Alley served as DEKA’s interface consultant on the LUKE Arm project. With Alley’s socket technology, patients went from rejection of the bionic arm due to its weight to enthusiastic acceptance. Chuck, a bilateral upper limb study participant, stated the “HiFi is the best invention in 100 years.” Featured here is Ryan testing the Gen3 LUKE Arm with Alley’s XFrame.
Alley conceived the threadless valve concept, and with the help of tranfemoral amputee Adam Soss and engineer Dustin Bouch, created the world’s first threadless valve family for preparatory and definitive suction socket applications.
“Many of today’s valve designs haven’t changed significantly in their approach to providing suction suspension since they were conceived decades ago,” said Alley. “I wanted to create a valve that was an improvement over existing valves and ultimately one that is easier for patients to use–hence the idea for a threadless design.”
The PushValve is a latching, threadless auto-expulsion valve designed primarily for above-knee suction socket applications, Alley explained. The lower-profile MagValve is a magnetic threadless auto-expulsion valve suitable for both upper- and lower-extremity suction sockets.
“The main advantage of the threadless valve design is that it does not require any twisting, but instead can quickly and effortlessly push in and pull out,” according to a company statement. “In addition, audible feedback lets a patient know they are properly seated and secure: they just click into place. No special tools are required for tightening/loosening, and there is no threat of pulling hairs. The valves are also ideal for bilateral amputees and individuals with hand involvement who wouldn’t be able to easily manage existing screw-in valves. Both valves are also perfect for active individuals who have a need for speed.”
To purchase the valves for your patients’ prosthetic sockets visit ottobocks website. https://shop.ottobock.us/Prosthetics/Lower-Limb-Prosthetics/Socket-Technologies-Liners/Valves/c/1606