Simple surface sulfonation retards plasticiser migration and impacts upon blood/material contact activation processes

Area of Science:

• Biomaterials Science
• Polymer Chemistry
• Medical Device Engineering

Background:

• Di-2-ethylhexyl phthalate (DEHP) plasticised polyvinyl chloride (DEHPPPVC) is widely used in medical devices.
• DEHP migration from these devices poses potential health risks.
• Surface sulfonation has been identified as a method to reduce DEHP migration.

Purpose of the Study:

• To investigate the efficacy of surface sulfonation in reducing DEHP migration from DEHPPPVC.
• To evaluate the impact of surface sulfonation on blood contact activation.
• To assess the safety and performance of sulfonated DEHPPPVC in vitro and in vivo.

Main Methods:

• Two-phase study involving migration rate measurements and a rat recirculation biomaterial test model.
• Quantification of DEHP migration from DEHPPPVC and sulfonated DEHPPPVC (SDEHPPPVC).
• Assessment of blood contact activation markers including CD11b expression, IL-6, and Factor XIIa levels.

Main Results:

• Sulfonation significantly reduced initial DEHP concentration and post-wash migration rates (p<0.0001).
• SDEHPPPVC showed reduced CD11b expression (p<0.01), IL-6 levels (p<0.01), and Factor XIIa levels (p<0.05) compared to DEHPPPVC.
• These findings indicate a moderation of inflammatory and coagulation responses.

Conclusions:

• Surface sulfonation is an effective method for retarding DEHP migration from DEHPPPVC.
• The sulfonation process significantly moderates blood contact activation processes.
• This approach offers a promising strategy for enhancing the safety of DEHP-containing medical devices.