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Are You Able to Manage Bright Ideas and Promote Innovation?

By Biodesigns, biomechanics, Food for thought, HiFi, Lower Extremity, Military, Orthotics, Prosthetics, Upper Extremity
By: Julie Alley
Recently saw a “Bight Ideas” post and cartoon on LinkedIn (thanks Brent) stating how we manage and encourage bright ideas will determine the future of O&P. I have thought about the question of product and technique adoption a lot, as one of our goals is to improve the standard of care in interface designs in O&P, but more generally, improve all limb device integration.
   
Over the years, I have seen it is easier to ignore bright ideas or new discoveries instead of embracing them quickly. Look at Edison. Few could understand the life-altering benefits of the light bulb. And we see this time and time again. Many products take years to gain traction or adoption. So why are we so slow to move and why would someone ignore a bright area or new discovery? For me, everything comes down to motivation and if you are personally motivated to do something. So what motivates someone to disregard or pass on a big idea? Now I’m no psychologist and I don’t claim to be one, but I believe there are many possible answers. Is it pure laziness, a good enough mentality, complacency, or I’ve done it this way for so long that I don’t want to change? Is it ego or not created it here syndrome? Is it not knowing enough about something or the inability to comprehend the idea? Is it seen as helping the competition? Is it insecurities? Is it easier to try and rip it off? Is it a fear of failing? Is it a bad manager or supervisor? Is it too many distractions, the belief that it would take too long to implement, perhaps a disbelief in the benefit of the new idea or product, one not seeing it as being valuable or worth the price or investment? Is it short term vs. long term thinking, is it distractions at work or home, is it not having stake in the new idea, is it tunnel vision, is it how or what you were taught in school the dictates your world view, is it not a priority, and the list goes on. Coming from outside the industry into this industry, I quickly noticed that the value of the prosthetist is minimized and the main focus is on the components, with the threshold for success being acceptance or delivery of the device at that one moment in time, even before the patient has had ample time to test and use the device. If this is the best we can achieve, then innovation, at least in the interface will never be achieved by the masses. If the industry can look at themselves and say our high risk of falls in femoral and tibial prostheses, and low acceptance rates in upper limb, is not acceptable, then maybe there is hope. For us, biodesigns will continue as a company to push for superior interfaces, as this is the platform or core for the whole system. And we will stand with the few also pushing for improved designs, with the hope that the industy will follow. If the role of the prosthetist and interface continues to be minimized, reimbursement will continue to fall. The schools/master programs can help push the change, but if they continue to focus on the past with very little emphasis on newer designs, outcome measures, biomechanical principles, gait analysis, functional range of performance, energy expenditure, alignment, soft tissue management, etc., the future O&P clinicians, will have much to learn. And if the prosthetist doesn’t learn how to fight for their place in the system, based on an experience and expertise few other allied health professionals have, then you will be replaced. Anyone can learn how to take a few measurements and send them to fabrication. But very few can make a patient who has lost a limb feel whole again.

biodesigns Announces New HiFi Digital Program

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

Prosthetic Interfaces for Improved Outcomes and Efficiency

Southern California-based biodesigns, inc., the leader in non-surgical human interface development and attachment technology, is pleased to announce the patented and patents-pending HiFi Rapid Technology Deployment (RTD) Digital Program for the creation of biomechanically-superior prosthetic interfaces. The RTD Digital Program utilizes the highly successful patented and patents-pending HiFi Interface™ technology while leveraging innovations in scanning and 3D printing, for improved patient outcomes and operational efficiencies. The RTD Program is being introduced initially to a limited number of existing HiFi Trained and Licensed Orthotic and Prosthetic (O&P) Facilities throughout the country, with plans for a full global roll-out in 2022.

“There are several scanning/3D fabrication programs currently available to prosthetists, but their entire focus lies in simplifying the process and achieving faster turnaround,” stated Randall Alley, CEO and Head of User Interface Technology at biodesigns, inc. “And while much improvement has been made in the speed and ease of the fitting process with advanced fabrication technology, this does not compensate for poor interface biomechanics. So you end up receiving primitive socket designs, but they’re delivered quickly and efficiently, not an ideal scenario. The primary focus should always be superlative interface performance and superior patient outcomes, bolstered by a simple and efficient process of shape capture, rapid revision and turnaround.”

The RTD Program is the latest product offering from biodesigns and allows for a more simplified HiFi program with consistent results, regardless of the skill or experience of the prosthetist, and at a much lower entry price.

“We wanted to introduce the RTD program into the field for the last several years, but the 3D printing technology was not where we needed it to be. Now with the introduction of our patented handheld HiFi Freestyle™ dynamic compression equipment, advanced CAD/CAM software for modifications, and our Filament Innovations Icarus printer for transparent and extremely strong HiFi diagnostic interfaces in record time, we have a unique fabrication program that exceeds all others. It’s as easy as compress, scan and send, and we will do the rest.”

Trained prosthetists will have the option of using a HiFi Authorized C-Fab Center or using their own in-house fabrication for definitive interfaces. The RTD Program has several options based on the size, capabilities, and license purchased by the O&P facility.

Critical to the new RTD Program is HiFi’s patent protection. biodesigns’ robust patent portfolio includes Method of Manufacturing Prosthetic Socket Interfaces (US10,878,137), Methods for Bone Stabilization, (US10,702,404, US10,123,888), Methods for Use of Compression Stabilized Prosthetic Socket Interface, (US8,323,353), Method, System, and Tools for Affixing Compression Stabilized Prosthetic Socket Interface, (US8,656,918), Adaptable Socket System, Method and Kit (US9,283,093, US10,369,027, EP2914221B1, and CA2,889,918), System and Method for Engaging Target with Artificial Limb Equipment (CN106913407B), and Adjustable Pod System, Method and External Member (CN104884005B).

For more information visit www.biodesigns.com

About biodesigns:

Southern California-based biodesigns, inc. is a technology-driven facility specializing in the most advanced patient care, research and product development in non-surgical Human Device Interfaces. In prosthetics, it is reestablishing a connection that has been lost; with the military, it is enhancing mission-critical performance and reducing injury; and in consumer wearables it is improving the way individuals interact with tech, tools, and gear. biodesigns’ mission is to create the universal interface standard for Orthotics & Prosthetics (O&P), Exoskeletons, Orthopedics, and consumer wearables and deploy it worldwide. biodesigns’ intellectual property portfolio is managed by Fish IP Law LLP, a premier intellectual property law firm.

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Our Brain Can Change and Adapt, But Can You?

By Articles, Biodesigns, biomechanics, HiFi, Prosthetics, Socket Technology

In prosthetics, our ultimate goal should transcend the physical act of mere device delivery and extend into the realm of total device embodiment. This research is very interesting as it highlights the brain’s ability to adapt and change in significant ways. Prosthesis acceptance is a problem many struggle with and it is evident from the feedback we receive from amputees and others. Many prosthesis wearers come to us specifically because they are seeking a better connection to their prosthesis. They report that they feel very disconnected from their px, often stating it feels heavy, uncomfortable, inefficient, and unstable, resulting in a high risk and fear of falls. On the contrary, in our clinic and with our HiFi Licensees, we continue to document that most of our HiFi Prosthetic Interface wearers state their prosthesis feels like a part of them, feels significantly lighter, moves with them, and many report phantom sensations lost long ago now returning, allowing them to feel the ground, make quick adjustments and prevent falls. Some even forget they are wearing their prosthesis, the ultimate indication of device embodiment. I believe this to be the result of our High-Fidelity Interface’s emphasis on proper biomechanics, a term too often tossed around casually when referring to standard of care sockets with near total disregard for uncontrolled bone motion. Proper biomechanics is impossible if the primary mover is flailing about within the socket. With our patented and patents-pending osseostabilizing technology that was designed from its inception to control unwanted translation of the underlying bone shaft, we achieve a syncing of the prosthesis with skeletal motion. This synchronization in concert with a strongly activated fascial sensor network from targeted compression is a better match to the condition experienced prior to limb loss, allowing natural stimulation of the brain that is more representative of a sound limb. With skeletal control, the wearer can distance themselves from the artificiality of poorly connected prosthetic devices, allowing their brain to better “accept” this new condition and more fully incorporate it into the sense of self. In other words, get on with the business of living. While this is a great breakthrough in prosthetic technology, the limiting factor here is not our brain, as noted above, it instead is our industry’s reluctance to change, inability to break long established fitting habits (that yield subpar results), and refusal to acknowledge that perhaps the way we did things in the past was detrimental to our patients. My hope is to continue to work with those individuals, researchers, allied health professionals, etc., that continue to look forward – not backwards.

https://interestingengineering.com/human-brain-can-support-extra-robotic-body-part-third-thumb

Alley Introduces the “Biotensegrity Bridge” for Human Device Interfacing

By Biodesigns, biomechanics, Food for thought, HiFi, Prosthetics, Socket Technology

In the March 2021 issue of the O&P Edge, Randall Alley, CEO and Head of User-Interface Technology, notes the issues with existing prosthetic socket designs and introduces a new model to consider for attachment, the Biotensegrity Bridge™, and describes how the patented and patents-pending HiFi Interface™ System creates a stable and functional “bridge” for attaching prosthetic devices.

“Since soft tissue (fascia) has a nonlinear stress/strain arrangement, traditionalists have incorrectly applied linear laws using levers and pulleys (mechanical physics) to explain the effects that the forces of gravity and tension elicit on our bodies. Biotensegrity has emerged as a new model of structural biology that is in diametric opposition to the Newtonian model of linear mechanical forces we all learned in school. Understanding the dynamic and continuous relationships between the soft tissue (fascia) and fluids within the body opens up new and exciting opportunities for better understanding the nature and role of the human-device interface,” stated Alley. “I give you what I am terming the Biotensegrity Bridge™ as a better way to approach interface integration.”

Read the full article: https://opedge.com/Articles/ViewArticle/2021-03-01/human-device-integration-introducing-the-biotensegrity-bridge

Captain DuVal and Alley Highlighted

By Biodesigns, HiFi, Military, Prosthetics, Upper Extremity

Exciting week end of the year as biodesigns was visited by Fox11 and ABC channel 7 regarding the innovative prosthetic work we are involved in with Captain Carey DuVal, right, below elbow amputee, and BrainRobotics.

Check out some of our coverage:

https://abc7.com/technology/veteran-tests-new-technology-with-robotics-prosthetics/8702452/ 

https://www.foxla.com/news/westlake-village-prosthetics-company-tests-state-of-the-art-bionic-arm

https://sofrep.com/news/army-captain-becomes-first-soldier-with-a-prosthetic-limb-to-complete-special-forces-selection/

https://www.washingtonpost.com/technology/2020/12/23/innovations-bionic-hand-ai/

So glad to share this story with others. We hope it provides encouragement and inspiration.

 

My Personal Experience Pursuing Innovation in the O& P Field

By Biodesigns, Food for thought, HiFi, Prosthetics

It’s not difficult to get a patent if you have a novel idea and know how to explain it well. With my HiFi Interface technology, I was pressed by examiners many times with prior art, and often, though it was easy for me to know the differences, it was challenging to find attorneys that could convey those differences in a way that made it easy for the examiners to understand and appreciate. Once I found a legal team I felt was the right fit, the objections became less and less of an obstacle and more of a fun exercise. When I look back at my experiences, I could have never guessed that interface innovation would take so long or be such an uphill battle in terms of acceptance into the O&P field.

Along my journey, I have noticed there are several types of clinicians: 1) those committed to providing their patients with the best outcomes/results, regardless of where the technology comes from; 2) those that want to put down innovation or discredit it due to “not invented here” biases or misconceptions about what is truly novel; 3) those stuck in the past with no desire to change or try new ideas; 4) those that focus on bells and whistles, components doing all the work, or aesthetics instead of focusing on the core interface connection;  5) those that are more interested in speed and convenience for them or their staff over what is best outcomes for their patients, and finally; 6) those that blame the patient for poor interface performance.

I have a question to pose to our readers, which one fits you best? While we stand on the shoulders of giants from the past,  there are new giants among us, awaiting their next big idea. At biodesigns, we are betting on osseostabilization™ and have received multiple patents for our technologies. When patients’ lives are on the line, I see a significant shift in mindset is necessary. In Gottschalk’s famous article on femur bone control, my point is perfectly illustrated. Gottschalk was convinced the femur couldn’t be controlled with any then current or previous socket designs and that surgery was required. He was absolutely right when the article was published in 1989. Thankfully, things have changed and I believe the key is omnidirectional stabilization of the underlying bone and mimicking intended skeletal motion to maximize prosthetic embodiment.

We need to continually strive for improvement and push our industry to do better. It is with the utmost conviction I believe clinicians should focus more on science and interface biomechanics, and less on art. Sure the two can and should coexist. But our threshold for success has been too low for too long. Our primary goal must be far more than achieving patient tolerance of our devices, or making the interface look cool using additive manufacturing or colorful materials as a panacea for poor socket design. We first should be asking ourselves, did the wearer get their life back, and did we, to the best of our ability, come even remotely close to returning what they lost. As new materials and processes are introduced into the field, including scanning and 3D printing, it’s easy to be more excited about the way the socket looks, but if the same issues are occurring (high levels of falls, instability, rotational issues, pistoning, uneven gait, discomfort, lack of proprioception, etc.), although I can appreciate the benefits of new materials, perhaps we shouldn’t be patting ourselves on the back quite yet.

-Randall Alley, CEO, biodesigns

Biodesigns presents at 2020 SoCalBio Conference in Los Angeles California for Innovative Prosthetic Socket HiFi Interface

biodesigns To Present at SoCalBio’s Annual Conference, Oct. 21-23, 2020

By Biodesigns, Exoskeletons, HiFi, Prosthetics, Socket Technology
Biodesigns selected to present at 2020 SoCalBio Conference for innovative prosthetic socket HiFi Socket

biodesigns has been selected to present their High-Fidelity Interface Technology at the upcoming SoCalBio’s annual meeting. This year the event will be virtual, allowing more people to attend. biodesigns’ presentation will be during the emerging company presentations on Friday, Oct. 23rd, 2020. biodesigns will be highlighting their HiFi osseostabilization and osseosynchronization technology and it’s application in the areas of prosthetics, exoskeletons, and wearables.

The companies were selected from a large pool of applicants by members of SoCalBio’s Innovation Catalyst Program, a unique network of senior bioscience and healthcare professionals who provide presentation and business coaching for SoCalBio Conference presenters.

“The Annual SoCalBio Conference is a unique opportunity for emerging Southern California healthcare companies to present their vision to investors,” said Peter Blaisdell, PhD, Chairperson of the SoCalBio Innovation Catalyst Program. “Beyond funding, the conference allows participating companies to build relationships with industry peers and allied service providers vital to their growth.”

To learn more about the event or to get tickets, visit: www.socalbio.org

Randall Alley Hosts HiFi Overview Webinar 6/3

By Lower Extremity, Prosthetics, Upper Extremity

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 DuVal – First Amputee to Attend Special Forces Qualification Course

By Biodesigns, HiFi, Military, Myoelectric, Prosthetics, Socket Technology, Upper Extremity

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 Awarded Phase I SBIR Contract for Exoskeleton Interface From Army

By Biodesigns, Exoskeletons, HiFi, Military, Press Release / Media, Prosthetics, Socket Technology
WESTLAKE VILLAGE, Calif. – biodesigns, inc., Southern California, was awarded a Phase I Small Business Innovation Research (SBIR) contract from the Department of the Army, U.S. Army Research and Engineering Command, for their proposal, “Bio-Inspired Interfaces for Osseostabilized Human-Exoskeleton Connectivity.”
Randall Alley, biodesigns’ Founder/CEO and Head of User-Interface Technologies, will serve as the Principal Investigator (PI) on the Army contract, and will utilize his team’s experience in human connection technology to design a paradigm altering, innovative, exoskeleton interface attachment design.

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 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.

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.

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

 

 

 

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

By HiFi, Knee Technology, Lower Extremity, Prosthetics, Socket Technology No Comments

 
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

 

Jason’s Bionic Arm – HiFi Interface, Coapt, LTI Elbow, I-Limb Hand

By Biodesigns, biomechanics, HiFi, ilimb, Myoelectric, Prosthetics, Socket Technology, Upper Extremity
“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.”

 

Amputee Has Shocking Reaction to her Socket

By Biodesigns, biomechanics, BK, HiFi, Prosthetics, Socket Technology

Arlene, a below-knee amputee for almost 20 years, couldn’t believe the difference between her traditional socket and her new HiFi. With the HiFi, “it feels so much more natural. I don’t have to think about walking. That’s Amazing!”  In my old socket, it “feels like I’m going to go down. The knee is going to buckle. It’s a little scary.” Arlene shows the HiFi can help users of all ages. Everyone can benefit from HiFi’s ability to provide added stability and control.

Biomechanical Design Considerations for Transradial Prosthetic Interface: A Review

By Biodesigns, biomechanics, HiFi, Prosthetics, Socket Technology, Upper Extremity

DARPA’s Revolutionizing Prosthetics Program

By Biodesigns, DARPA, HiFi, Military, Myoelectric, Press Release / Media, Prosthetics, Socket Technology, Upper Extremity

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.

First Threadless Valves for Suction Sockets Sold to Otto Bock Healthcare

By Biodesigns, Lower Extremity, ottobock, Prosthetics, Upper Extremity
Randall Alley, BSc, CP, owner of biodesigns inc., Westlake Village, California, announced that the PushValve and MagValve, two threadless auto-expulsion valves for upper- and lower-extremity prosthetic suction sockets, have been sold to Otto Bock Healthcare, headquartered in Duderstadt, Germany.

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