BILECOAT Develops a biliary stent coating to keep stents open

A project of Lipocoat Group and the University of Twente. BILECOAT runs for 24 months and takes a LipoCoat® lipid coating from an early prototype to a validated demonstrator for biliary stents. The project is listed in the Health~Holland project overview.

The problem: a stent that clogs

A biliary stent is a small tube that keeps the bile duct open when gallstones, a stricture or a tumor block it. Over time, bacteria form a biofilm on the stent and bile components build up on its inner surface. The stent narrows, bile flows more slowly and the risk of infection rises. In the worst case the duct blocks again, and the patient needs another endoscopic procedure (ERCP) to clear or replace the stent.

The scale is large. The project partners estimate that about 250,000 biliary stent procedures take place in the EU each year. If 30–40% of these patients need at least one repeat ERCP because of occlusion or related complications, and each occlusion event costs roughly €10,000 once the repeat procedure, hospital stay and complication management are counted, the yearly burden for European healthcare is in the order of €1 billion.

The approach: a coating that stays attached and stays clean

BILECOAT combines two ideas. The first is a polymerized lipid layer. In early laboratory work, polymerized diacetylene lipids reduced fouling by more than 85%. The second is tethering, a way to bond that lipid layer permanently to the stent surface. Together they form a next-generation coating that targets biofilm formation, bile fouling and the infections linked to them.

The project starts at Technology Readiness Level (TRL) 3/4 and aims for a validated demonstrator at TRL 6.

What BILECOAT delivers

• A robust tethering strategy that attaches the polymerized lipid coating to biliary stent surfaces.
• Structured verification and validation testing of the coated stent.
• A validated demonstrator at TRL 6, as the basis for industrial development of biliary stent surface modification.

Partners in BILECOAT

• Lipocoat Group: LipoCoat® lipid coating technology.
• University of Twente: academic partner.

Why it matters

A stent that stays open longer means fewer replacement procedures for patients, less endoscopy workload and fewer unplanned hospital admissions. If BILECOAT reduces occlusion-driven re-interventions by 20–30%, the partners estimate savings in the order of €200–300 million per year for European healthcare systems. The same approach can open the way to other gastrointestinal (GI) applications.

What this means for device manufacturers

LipoCoat® is applied to existing medical devices, so a manufacturer can add a function without redesigning the device. BILECOAT builds the tethering strategy and test data for biliary stents. Manufacturers who want to evaluate LipoCoat® on their own device can start with a feasibility study.