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.
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.”
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.
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 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.