All Posts By

julie alley

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

biodesigns Announces 11th Patent for Interface Technology, Expands Licensing Program

By | Biodesigns, Press Release / Media, Socket Technology, Uncategorized

WESTLAKE VILLAGE, Calif., Dec. 19th, 2020 – Southern California-based biodesigns, inc., the leader in non-surgical human interface development and technology, is pleased to announce another patent for their innovative High-Fidelity™ (HiFiTM) Interface technology. This latest patent, Method of Manufacturing Prosthetic Socket Interface (US10,878,137), complements their interface technology patent portfolio including Methods for Bone Stabilization, (US10,123,888, US10,702,404), 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, CA2,889,918), System and Method for Engaging Target with Artificial Limb Equipment (CN106913407B), and Adjustable Pod System, Method and External Member (CN104884005B).

Randall Alley, biodesigns’ CEO, Chief Prosthetist, and Head of User-Interface Technology, has discovered a revolutionary approach for attaching items, equipment, tools and technology non-surgically to the body. The core of the patented and patents-pending HiFi™ Osseostabilizing™ Human Device Interface (HDI) technology is its ability to improve worn device performance and control by syncing the interface more effectively and efficiently to skeletal motion. By surrounding the underlying bone with an alternating array of compression, users experience improved connectivity, a heightened sense of proprioception, and a higher level of device embodiment, whether wearing a prosthesis, exoskeleton, or other wearable technologies.

“When I traveled the world for nearly 15 years fitting complex prosthetic systems, I continually witnessed poor outcomes  and high rejection rates caused by the Standard of Care (SOC) sockets being provided. Patients’ biggest complaints were discomfort and feeling disconnected from their prosthesis. It was then I decided to dedicate my career to improving the human device interface by focusing more on interface biomechanics to achieve improved comfort, increased user feedback, enhanced performance, and ultimately greater device acceptance,” stated Alley. “Today, I am pleased to see the HiFi™ interface technology expand into other industries. Our goal is simple – device embodiment so we can be one step closer to seamless human-device integration.”

To make the technology more accessible to patients globally, biodesigns licenses the HiFi™ Prosthetic Interface technology to other Orthotic and Prosthetic (O&P) facilities in the U.S. and abroad, including several NHS (National Health Services) facilities who are interested in improving their outcomes for upper and lower limb prosthetic wearers. Additional programs include a license to their exoskeleton interface technology as well as a license to their recreational consumer interface products, including exolimb™ which is scheduled to launch in 2021.

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 in Orthotics & Prosthetics (O&P), Exoskeletons, Orthopedics, and consumer wearables. biodesigns’ intellectual property portfolio is managed by Fish IP Law LLP, a premier intellectual property law firm.

For more information visit www.biodesigns.com

###

The Importance of the Prosthetic Interface and Its Impact on Patient Management

By | Lower Extremity, Socket Technology, Upper Extremity

The Interface or Socket that the Prosthetist provides has a profound impact on their patient’s ability to move forward with rehab and greatly impacts their life today and in the future. Read the recent article by Tricia West and Randall Alley. We must remember to think of our patients in the hear and now but maybe, and even more importantly, in the future.

https://www.aanlcp.org/wp-content/uploads/2020/10/Fall-2020.pdf

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.

 

biodesigns First Facility in US to Test BrainRobotics’ Myoelectric Hand, Captain Carey DuVal First US Amputee

By | Biodesigns, HiFi, Myoelectric, Press Release / Media, Uncategorized, Upper Extremity

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

WESTLAKE VILLAGE, Calif., Dec. 1, 2020 – Southern California-based biodesigns, inc., a biomechanically-focused, outcomes-driven, prosthetic clinic and human interface development company, has been engaged to test BrainRobotics’ new myoelectric prosthetic hand with select prosthesis wearers, including transradial (below elbow) amputee, US Army Captain Carey DuVal.

When determining who should test their new hand terminal device in the US, BrainRobotics searched online and connected with individuals in the O&P (orthotic and prosthetic) and adaptive community, including Adaptive CrossFit coaches. BrainRobotics noted that transradial amputee Captain Carey Duval, and other high-functioning amputees, stressed the critical importance of their interface or socket to their overall success and improved prosthesis performance. Captain Carey DuVal, under the care of Randall Alley, CEO and Chief Prosthetist at biodesigns, originally sought out Alley for his patented and patents-pending High-Fidelity™ Interface technology out of frustration with existing sockets that were holding him back from performing at an elite level.

“The High-Fidelity Interface with Osseostabilizing™ technology is a complete departure from Standard of Care Sockets. The HiFi Interface focuses on manipulating soft tissue via an alternating, circumferential array of targeted compression to capture the wearers’ underlying bone to better control and sync the interface and hence the prosthesis with skeletal motion. This provides the user with improved function, improved range of motion, enhanced stability, added proprioception, and overall improved component and prosthesis satisfaction,” stated Alley. “Carey needed a system that could keep up with him. A veritable “super-user”, he is the perfect person to test our HiFi Interface with the BrainRobotics’ hand.”

The fitting process and socket design utilized will often determine whether a component or prosthesis is ultimately accepted or rejected by the wearer. A main goal for BrainRobotics’ US marketing strategy, as they await FDA approval, is to engage users and prosthetists that have demonstrated high levels of success, to test all parts of their system, including hand function and ease of fabrication. Currently BrainRobotics is targeting an official US launch in Q1 2021.

“With the BrainRobotics’ hand I quickly noticed the grip system seemed to be more intuitive and very responsive, allowing me to switch easily and quickly between different grips,” stated Captain DuVal.

“Our initial feedback is very positive, and this with only the 2-site option being tested,” stated Alley. “I expect even more encouraging results when the 8-channel system with embedded pattern recognition becomes available for us to evaluate.”

About BrainRobotics:

The BrainRobotics’ hand design is based on research that began in 2015 in the Harvard Innovations Lab and leverages advanced BMI (brain/machine interface) technology to deliver more capability, usability, and affordability to the prosthetic industry. The initial US product launch will consist of the 2-site myoelectric version available for transradial amputees or those with congenital amelia, with a more advanced, 8-channel version to include pattern recognition and AI integrated into the arm system. While there are several prosthetic hands currently available for upper limb wearers, the goal of the BrainRobotics’ hand is to complement function with greater intuition, while making the system more affordable and accessible. BrainRobotics’ goal is to have a terminal device package, including the hand, wrist, electrodes, batteries, and charger, at a cost 30% below existing prosthetic hand solutions.

About Captain Carey DuVal:

Carey DuVal, a transradial amputee as a result of a VBIED attack during combat deployment to Afghanistan in 2014, made history as the first amputee to be selected during US Army Special Forces Assessment and Selection to attend the prestigious Special Forces Qualification Course (Q-Course). Captain DuVal credits his HiFi Interface as the game changer and reason he was able to perform at such an elite level. “I notice my body is much more symmetrical now as I don’t favor my sound side,” he said. “I’ve recently gotten back to all of my previous max lifts. The HiFi allows me to do things that no other socket in the world can do.” Capt. DuVal also participates in CrossFit and competed in the WheelWod open and qualified for the WheelWod Games. WheelWod is the adaptive version of the CrossFit Games and, like CrossFit, includes aerobics, weightlifting and gymnastic movements. Currently stationed at Fort Bragg, Capt. DuVal will be retiring within a year and he intends to put his experiences with prosthetics to help others by training as a physical rehabilitation specialist for amputees.

About Randall Alley, biodesigns:

Randall Alley is CEO, Chief Prosthetist and Head of User-Interface Technologies for biodesigns. Alley is a board-certified prosthetist and received both his prosthetic certificate and Bachelor of Science in Kinesiology from UCLA. Alley has 30 years experience fitting challenging prosthetic patients and was co-founder and former director of the world’s largest upper limb prosthetic program. It was his dissatisfaction with the numerous issues cause by the Standard of Care Prosthetic Sockets that led him to dedicate his career to improving the interface. Alley was also the Principal Investigator on two SBIR/DOD contracts, has contributed to five upper limb prosthetic and orthotic textbooks, received a Certificate of Appreciation from the US Army, the Clinical Creativity Award from the American Academy of Orthotists and Prosthetists, was the Interface Consultant on DARPA’s/DEKA’s Bionic LUKE Arm Revolutionizing Prosthetic Program, and has over 10 patents for his human attachment technologies.

For more information, visit www.brainrobotics.com

###

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 Delivers Advanced Arm During Corona Virus Outbreak

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

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.

 

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.

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