Above: Aspero's inflated balloon with PillarTM Technology
Below: Molding technology used to build medical balloon
Aspero Medical has received a patent for new technology that will help physicians diagnose and treat gastrointestinal illness more effectively. The medical device startup, cofounded by Paul M. Rady Department of Mechanical Engineering Professor Mark Rentschler, created a micro-textured medical balloon for endoscopies.
The new patent covers the startup company's PillarTM Technology, the small nubs on the balloon made of silicone. The pillars are shaped and spaced out in a way that creates more friction, which allows doctors to secure the balloon in the small intestine. Medical balloons made by other companies are smooth and tend to slip in the mucus lining the intestine. Those balloons make endoscopies technically challenging and time-consuming.
"We feel like we're able to give better traction and better anchoring with less force," Rentschler explained. "Speed for the physician, deeper access for the patient, less trauma and full diagnosis and treatment that first time."
Balloon endoscopy is the standard to diagnose and treat small bowel disease. The balloon is inflated when inserted into the intestine, making room for a scope to move through. The procedure allows physicians to see the entire small intestine.
One of Rentschler’s goals is to “figure out a way to try to make a bigger impact with our discoveries at the bedside with the patient and the physician.” His new Pillar TM Technology helps push that mission forward.
Engineering the micro-textured balloon
Companies have tried designing balloons with texture before, but not like this. Rentschler said the idea in the early 2000s was to use mesh around a balloon. When the balloon was inflated, it would squish through the holes of the mesh to create nubs intended to secure the balloon.
Rentschler's technology takes a more engineered approach using a molding design. Aspero Medical created a mold with pockets for each pillar. Silicone is injected into the mold and pushed into each hole.
“We wanted something super thin,” Rentschler said. “While we want the textures, we don’t want them to break. We want them to be as small as reasonably possible.”
While Rentschler pointed out that molding technology has improved in the last five years, the process to create such small pillars is not easy.
“In fall 2019, we started proving out our technology by transitioning to manufacturing and building our first micro-textured balloons at scale,” Rentschler explained. “That itself was a huge challenge. Most contract manufacturers wouldn’t even try to create these balloons with us because they didn’t think it was possible.”
Once Aspero Medical found a vendor ready for the challenge, the startup began building the balloons in spring 2020.
Rentschler created the Pillar TM Technology with Dr. Steven Edmundowicz, Aspero Medical’s chief medical officer and the medical director of the Digestive Health Center at the University of Colorado Anschutz Medical Campus. The foundational intellectual property was developed at the University of Colorado. The CU Board of Regents owns the patent.
Utilizing the technology on medical products
Aspero Medical uses the micro-textured balloon in a product the company has lined up to submit for FDA approval.
The AncoraTM Balloon Overtube attaches the pillared balloon to a silicone tube for endoscopies. Physicians move a scope through the silicone tube to visualize the digestive tract. Rentschler and Edmundowicz will apply for FDA approval this year. Rentschler said if all goes well, they expect approval three months after submitting. From there it’s commercialization.
Aspero Medical also plans to use the Pillar TM Technology on a product for colonoscopy procedure. The company intends to submit that product for FDA approval in 2022. The Pillar TM Technology is designed so that it could work with other balloons as well. That could include balloons used in cardiovascular or urology procedures.
“This product (Ancora Balloon Overtube) is for GI. Our second product is for colonoscopy, again GI,” Rentschler said. “We’re starting to put our heads together on what we think could be third.”