Outside Experts Revitalize Low Back Pain Device

Co-inventor Daniel Pendleton Demonstrating the Back-Rollieve Device

Outside Experts Revitalize Low Back Pain Device

TVC’s Commercialization Engine helps to restart “Back Roll-ieve,” a device designed to alleviate low back pain at home

TVC’s Commercialization Engine Committee was formed in 2011 to help build a network of experts from which TVC could rely on to help advance U technology. Since that time, members of this committee have been responsible for many important commercialization advancements. One of these has been with a device designed by U physical therapists Tim Henry and Dave Carter to help people with chronic low back pain achieve relief at home.

Called “Back Roll-ieve,” the device stretches the spine so that pressure is taken off of the spinal disks and the nerves in-between. To experience this relief, users unfold the compact unit to set it up, lie down on their back underneath its two front arms, align their hips with the device’s front, attach a harness to their hips, rest their lower legs up on a tray that hangs from the top of the device, and then adjust the amount of stretching to the lower back by using harness height adjustment mechanisms on the side.

According to Carter, this stretching action, known as spinal decompression, or traction, may result in the relief of various types of low back pain such as stenosis, degenerative joint disease, and facetogenic pain.

Carter and Henry’s device couldn’t come at a more opportune time. Chronic low back pain amongst adults has increased significantly over the past 20 years. In 1992, 3.9 percent of Americans reported this condition. By 2006, this number had grown to 10.2 percent. It is also the second most common reason for disability in the U.S. and results in some 149 million lost workdays each year.[8]

Inventors (left to right): Dave Carter, Daniel Pendleton, and Tim Henry

According to Carter and Henry, it is common for physical therapists to check to see if spinal decompression will benefit a patient with low back pain. For those it does help, patients are often prescribed expensive treatment plans on costly decompression tables at physical therapy clinics of anywhere from 12 to 20 treatments, a range often defined and capped by insurance companies.

“The major impetus for us creating this device was our patients often asking us, ‘How can I do these treatments at home? Spinal decompression really helps me,’” explains Carter.

Before developing Back Roll-ieve, Carter and Henry acquainted themselves with the various home back traction products on the market but believed that most were either potentially dangerous for certain people, too expensive, hard to use, or simply ineffective. As such, they decided to create their own device. The goal was to make it effective, easy to use, comfortable, and inexpensive.

Carter and Henry came up with the first design of their back traction device and disclosed it to TVC in 2012. In 2013, TVC awarded it with Commercialization Engine funds for prototype development. Carter and Henry used these funds to partner with a Chinese firm who built the device to Carter and Henry’s specifications. “The result wasn’t exactly what we were expecting,” explains Carter. “The device was quite large and cumbersome. It would’ve worked great for Andre the Giant, but not so much for everyone else. It just didn’t pan out.”

Believing that Back Roll-ieve still had great potential, in 2015, Taylor Bench and Aaron Duffy of TVC decided that the device should be pitched to the Commercialization Engine Committee for another round of funding for further prototype development. This time, however, Bench and Duffy, in consultation with Carter and Henry, decided to seek outside engineering assistance. With a series of U inventions being rejuvenated by the growing number of external experts sitting on the Commercialization Engine Committee, Bench and Duffy decided to follow this path and contact a local precision engineering firm called Micron Solutions that had worked with TVC in the past. Daniel Pendleton, president of Micron Solutions, agreed to take on the project to design and manufacture a new prototype.

The Back Roll-ieve device

In the week leading up to the pitch before the Commercialization Engine Committee, Pendleton decided to make a cheap, wood-based prototype from Carter and Henry’s original specifications. He showed it to Carter and Henry and told them, “This is to your dimensions. This is what you asked for.” According to Pendleton, their reply was, “‘This won’t work. This isn’t really what we had in mind.’” After this first version two more wood iterations of the device were made that same week. These three versions, as well as the original prototype, were presented to the Commercialization Engine Committee as learnings for future development. “We told the Committee that this is what we’ve learned so far from the prototypes that were developed. We think we know where we need to go next; we just need the funds to do it,” explains Pendleton.

After this presentation, Back Roll-ieve was awarded additional funds from the Commercialization Engine for further prototype development and Pendleton and his team at Micron Solutions got to work. Several different models with various heights and shapes were tried based on the original design but none of these worked. “The goal of these first few designs wasn’t actually to come up with a final version,” explains Pendleton. “Rather, the goal was to observe Carter and Henry using them, ask questions, and see what these designs could and couldn’t do.”

After this period of observation, Micron Solutions decided to take a step back and focus on the core of the device, rather than its design. “We asked ourselves, ‘What are Carter and Henry trying to accomplish?’ ‘What is their mission?’” explains Pendleton. “A lot of engineers get anchored in a design. They try to make designs fit problems, but this rarely works. It’s important to take the 30,000 foot view when engineering devices, and that’s what we ultimately did here.”

While this new approach largely meant abandoning the original design and its subsequent iterations, it also meant that Carter and Henry’s original goals for the device would become more central than ever. With these objectives in mind, Micron Solutions created a completely new design of the device, one that Carter and Henry are quite pleased with. “We really have to pat Dan on the back for this latest design,” says Carter. “We finally believe that the device is ready for testing.”

In early 2016 the Back Roll-ieve team received additional funding from the Commercialization Engine. The goal of this funding is to make 10 prototypes and send them to various physical therapy clinics for testing and validation on patients. The feedback they receive from this testing will likely result in another version being made. After this, the goal is to make a more robust version for use in physical therapy clinics and, most importantly, a version for patients to use at home.

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[8] Janet K. Freburger, George M. Holmes, Robert P. Agans, ,Anne M. Jackman, Jane D. Darter, Andrea S. Wallace, Liana D. Castel, William D. Kalsbeek and Timothy S. Carey, “The Rising Prevalence of Chronic Low Back Pain,” Archives of Internal Medicine 469, no. 3 (February 2009): 251-258.