Pump therapy is more difficult than it needs to be due to infusion set reliability issues. Clinical studies have shown that approximately 30% of infusion sets are replaced before the end of 3 days of use due to failure. To solve the issues with infusion sets, we needed to learn what was happening under the skin. Our research team at Thomas Jefferson University learned a great deal about how the body interacts with an infusion set cannula. The body reacts in much the same way it would to a splinter – as a foreign object. The tissue responds by working to isolate the foreign material. This includes creating a barrier near the infusion set cannula.
Research has shown that this barrier is strongest at the tip – which is the only location insulin exits from today’s sets. This barrier prevents insulin from easily reaching capillaries and moving into the bloodstream. As the tissue response happens, insulin cannot easily get to where it needs to go. What it means to you is the need to replace your infusion set because your set has stopped “working” and you’re seeing a high blood glucose.
To improve the reliability of the infusion set, we have taken a 3-pronged approach. Together, these 3 elements are designed to ensure your body gets the insulin your pump delivers.
1. Slow the tissue response.
With current infusion sets, the stiffness of the cannula works to increase the tissue response. To slow tissue response, we selected a more flexible material for the SteadiSet™ cannula. With SteadiFlow technology, the cannula is far more flexible than other plastic cannulas and significantly more flexible than steel cannula.
The flexible SteadiSet material, allows the cannula to move with your body versus work against it. This is believed to result in significantly reduced tissue response over time and can help to preserve infusion sites.
2. Prevent kinking.
Plastic infusion sets can kink and block the insulin flow. To prevent kinks, we added a coil reinforcement to the interior of the cannula without adding thickness. The SteadiSet cannula is the same outer diameter as other plastic cannulas but kink-proof due to the coil. In testing the SteadiSet cannula with SteadiFlow technology the SteadiSet cannula never kinked.
3. Spread out the insulin into more tissue.
Our studies have shown that by adding three additional openings along the side of the cannula we delivered insulin into more tissue. The resulting insulin delivery has double the surface area versus traditional delivery at the tip of the cannula. A larger surface area means more capillaries are involved in the insulin uptake process by the body. We hope to be able to show that this leads to more predictable and reliable insulin absorption.
SteadiFlow Technology: the softer cannula material, coil reinforcement and 3 additional side holes work together to ensure you get the insulin you need.
SteadiFlow Technology vs Traditional Cannula Animation
CAUTION – Investigational device. Limited by United States law to investigational use.