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
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.
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.”