Category

Biodesigns

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, more 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

biodesigns Receives 6th US Patent for Prosthetic Interface Technology

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

Southern California-based biodesigns, inc., a biomechanically-focused, outcomes-driven, prosthetic clinic and human interface development company, is pleased to announce their sixth US patent for their innovative High-Fidelity™ (HiFiTM) prosthetic interface technology. This latest patent awarded July 7, 2020, Methods for Bone Stabilization (US10,702,404), complements their interface technology patent portfolio including Methods of Bone Stabilization (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 (US8,656,91), and Adaptable Socket System, Method and Kit (US9,283,093 and US10,326,027).

The core of biodesigns’ patented and patents-pending HiFi™ Osseostabilizing™ Human Device Interface (HDI) technology is its focus on capturing the underlying bone, to better control and sync the interface with skeletal movement. When motion and force are captured closer to the bone the prosthesis will react more instinctively, providing the user with improved function, performance, and proprioception.

“When I traveled the US for nearly 10 years fitting complex prosthetic systems, I continually saw the problems, poor outcomes, and rejection rates caused by the Standard of Care (SOC) sockets, especially for upper limb prosthetic wearers. It was then I decided to dedicate my career to improving the human device interface with more biomechanically-focused, outcomes-driven designs,” stated Randall Alley, CEO biodesigns and HiFiTM Inventor.

To help make their interface designs accessible to more patients in the US and around the world, biodesigns offers HiFiTM training events, including the upcoming HiFiTM Femoral and Tibial Interface training and licensing virtual event on Wed., Sept. 23th for Certified Prosthetists (CP’s) and Certified Prosthetists Orthotists (CPO’s). In this course CP’s/CPO’s will learn the principles of the HiFiTM design, how to utilize the HiFiTM Imager for diagnostic assessment as well as efficient casting or scanning, the HiFiTM modification technique, the clinical experience, research and data supporting the design, as well as reimbursement strategies.

In order to assist with enforcement and licensing of its intellectual property portfolio, biodesigns utilizes Fish IP Law LLP, a premier intellectual property law firm. To note, Hanger’s Comfort Flex, Sabolich’s Socket, Lim’s Infinite Socket, Martin Bionic’s Socketless Socket, the MAS Socket and REVO Limb do not have a license to the HiFi™ Interface technology. Prosthetists are encouraged to contact biodesigns if they believe they may have unknowingly utilized the HiFiTM technology in these or other socket designs.  

 

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.

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 an entire field-from prosthetists to manufacturers, to therapists to doctors to the media and to just about everyone else who is in some way, shape or form involved in prosthetics-is focused on everything but the problem that affects you, the one who has to live with it, the most: your socket, or as we prefer to call it, your interface.
Sure you hear people say “oh, 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 the attached accessories than the interface itself, what do you think suffers? Bingo!
At biodesigns, the interface is everything to us. Sure we provide the latest in cutting edge technology, and yes we’re probably more familiar with how to optimize manufacturer components than just about anyone else in the field. But tuning complex prosthetic systems is child’s play to us. 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 is no challenge. Having it stay on and be comfortable should be a given, not some great achievement. That’s like the prosthetist hitting the power button on your freshly delivered bionic leg and saying “yep, the light came on, I think we’re all goood.”
The serious challenges lay beyond simple comfort and suspension. Our focus is in extracting every ounce of effort you put in to the system and transferring it to the rest of the prosthesis. Our goal is to make you one with your entire system, 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 system. Do you think we arrived at that name by accident? Fidelity: the degree to which a copy of something shows the true character of the original. Cambridge dictionary. 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 this 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.

Prosthetic sockets stabilized by alternating areas of tissue compression and release

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

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 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.

 

 

 

Quadruple Amputee Lives Life To The Fullest

By | Biodesigns, HiFi, Socket Technology, Upper Extremity | No Comments

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.”
Download Full Release Here

Julie Alley, President, Chief Marketing Officer

Jalley@biodesigns.com

o/c: 310-717-1024

Randall Alley and The High-Fidelity Interface System have been featured in national media. Contact us to learn more.

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