Shouldering the Pain: A Shoulder Brace to Prevent Further Injury
The numbers are astounding: every year, more than 7.5 million people go to a doctor’s office for shoulder pain, upper arm sprains and strains. James R. Lebolt, DO, section chief and orthopedic surgeon, sports medicine, Spectrum Health Medical Group, sees more than a few hundred such patients annually for these types of complaints.
The most commonly used shoulder braces currently prescribed offer stability in the shoulder area , but their design, Dr. Lebolt says, has changed little since the 1980s and 1990s, when the braces were first made.
“They’re not much better than a typical over the counter bandage,” says Dr. Lebolt. “Athletes and post-operative patients need more support for the injured area while still allowing enough movement to function. These braces don’t offer that kind of support for anterior, posterior, or inferior instability or for general joint laxity. Consequently, if a patient has a weakened or unstable shoulder capsule that isn’t properly supported, it can lead to additional breakdown or injury.”
The Problem: Making the Instable Stable
According to Dr. Lebolt, joint laxity—or instability—often requires rehabilitation or even surgery to repair. Anterior or inferior instability occurs about 60 percent of the time in athletes, especially in athletes playing football, and posterior instability and multi-directional instability, while less common, make up the remainder of joint injury complaints.
“I had some rough ideas how to tackle the instability issue, and that’s when I remembered Spectrum Health Innovations had done presentations to our unit in sports medicine, telling us about what they do,” Dr. Lebolt says. “I thought, this is my missing link.”
Eric Van Middendorp, MSE, Spectrum Health Innovations, took on the project with Dr. Lebolt. The goal was to design a shoulder brace that provides adjustable and dynamic support for all types of shoulder instability—or prevents injury altogether. It needed to be easy to put on and easy to adjust by the patient.
“It has been great working with Dr. Lebolt,” says Van Middendorp. “He is extremely knowledgeable in this space and we have been able to lean on his expertise of the shoulder anatomy throughout the project. This was a challenging project initially because the market is crowded with many types of shoulder braces. However, Dr. Lebolt identified a clear problem which created a gap in the market that we have been able to address with a novel design.”
The Challenge: Braced for the Big Move
Sports participation is on the rise, and with higher participation comes a rise in the incidence of sports injuries. USA Today (August 2013) reported that more than 1.35 million children experience sports-related injuries in the United States every year. Shoulder injury is the second most common orthopedic soft tissue repair market, second to knee injuries and just above hip injuries.
Athletes are a large percentage of those who may need to use a shoulder brace at some point during their sports careers, but they are not alone. Others experiencing similar injuries include an aging population as well as a population with increasing rates of obesity. The orthopedic soft tissue repair market is expected to reach 8.5 million worldwide by 2019, according to MedDeviceOnline.com.
“We started by evaluating the existing products and patent landscape to verify that there was a clear gap in the market for a new product,” says Van Middendorp. “Clearly, there was.”
The Spectrum Health Innovations Solution: Restoring Freedom of Movement
“We looked at how certain injuries and anatomy can lead to several forms of instability in the shoulder,” Van Middendorp says. “In order to address the instability, Dr. Lebolt wanted a dynamic brace that could be adjusted for each patient’s needs, and we accomplished this by mimicking the biomechanics of a healthy shoulder.”
Van Middendorp explored Dr. Lebolt’s idea for an improved shoulder brace using both anterior and posterior dynamic tensioning with elastic elements, and from that, he created three concept sketches.
“After getting Dr. Lebolt’s feedback on the first sketches, we brought in an industrial designer, Tim Stoepker with Filter Studio,” says Van Middendorp. “He created two prototypes so that we could test the effectiveness of the designs. We are also creating a bench-top model to test the circular elastic elements and how they should be attached to the brace.”
Partnered with the designer, the team worked through several concepts for the shoulder brace and is currently receiving feedback from Dr. Lebolt and his colleagues in sports medicine, as well as from potential users. Once the design is refined using that feedback, a fully functional brace will be manufactured so that it can be worn and tested, then manufactured for all patients to use.
“Working with Spectrum Health Innovations has been an excellent experience. From the engineers to the clinical technicians and designers, it’s been pretty remarkable. The new shoulder brace should be functional right from the start once it is made. Having this kind of shoulder brace available will not only reduce injuries, but be a savings of lost work time and play time on the sports field for our patients.”
~ James R. Lebolt, DO, Section Chief Department of Orthopedics – Sports Medicine, Fellowship Trained Sports Orthopedic Surgeon, Medical Director, Sports Medicine Program, Spectrum Health Medical Group
“This project has been an excellent opportunity to collaborate within the community, including with Tim Stoepker of Filter Studios for design support and Nick Stygstra with Teamwork Design for prototyping assistance.”
~ Eric VanMiddendorp, Biomedical Engineer, Spectrum Health Innovations