The industry’s first tubeless and wireless insulin pump, recently upgraded by developer Insulet Corp, Bedford, Massachusetts, the US, features an insert molded Plunger made of TOPAS cyclic olefin copolymer (COC) from Topas Advanced Polymers.
The next-generation OmniPod Insulin Management System offers people living with insulin-requiring diabetes all the benefits of insulin pump therapy, while at the same time providing freedom and ease of use, and overall quality of life improvements.
The newly released OmniPod is 34% smaller and 25% lighter than the original model, and received 510(k) clearance from the US Food & Drug Administration (FDA) in December 2012.
The OmniPod Insulin Management System consists of the OmniPod which holds and delivers the insulin and the Personal Diabetes Manager (PDM) which communicates wirelessly with the OmniPod to program insulin delivery. The OmniPod includes a two-component insert molded Plunger which consists of a stainless steel Lead-screw and Fill Rod which are insert molded with TOPAS COC resin. The two-component Plunger has an elliptical shape and measures approximately 9.5mm by 15.9mm.
Topas Advanced Polymers says its TOPAS COC provides strong dimensional stability since the Plunger moves just 0.004mm per increment of insulin delivery. The dimensions of the Plunger and Lead-screw are critical because small amounts of insulin have a significant effect on blood sugar levels.
The OmniPod attaches directly to the body and is usable for up to three days of basal-bolus insulin therapy, delivering boluses of insulin after meals and in steady rates throughout the day. The OmniPod holds 200 units of rapid-acting insulin, which Insulet says meets the needs of most Type 1 diabetes patients’ three-day insulin requirements.
The material’s stability helps successfully manage the Plunger and Reservoir interface which is critical to the function of the device and provides adequate compression to maintain seal integrity, according to Kevin Schmid, Insulet’s Vice President of Business Development and Advanced Technology.
“TOPAS COC fills an important role in the drive system of the OmniPod Insulin Management System,” said Mr Schmid. “It’s a well-respected material because of its drug compatibility and other high-performance attributes.”
Unlike other engineering thermoplastics or glass, TOPAS COC offers a non-ionic, minimally reactive surface. This non-polar substrate does not promote adsorption, denaturation, aggregation, or precipitation. With lower leachables and extractables, glass-clear TOPAS resin preserves long-term drug purity enabling better quality at high yields, explains the company.
TOPAS COC, which provides purity, drug compatibility, biocompatibility, and dimensional stability, has been used in this critical high-performance Plunger since the first-generation device was commercialized in late 2005.