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Strain-induced crack formations in PDMS/DXA drug collars.
J A Warner1, J C Polkinghorne, J Gonerka
1Characterization Facility, University of Minnesota, Minneapolis, MN 55455, USA. jawarner@umn.edu
Acta Biomaterialia
|April 2, 2013
Summary
Assembly strain on cardiac lead drug collars creates microcracks, potentially increasing drug elution. This study investigates polydimethylsiloxane-dexamethasone acetate collars and their manufacturing impact on drug delivery.
Area of Science:
- Biomaterials Engineering
- Medical Device Manufacturing
- Drug Delivery Systems
Background:
- Drug-eluting systems on cardiac leads minimize inflammation and fibrosis at the lead-tissue interface.
- Manufacturing processes significantly influence drug release from these systems.
- Understanding material characteristics is crucial for optimizing drug delivery performance.
Purpose of the Study:
- To investigate the material characteristics of polydimethylsiloxane-dexamethasone acetate drug collars under varying assembly strain.
- To explore the impact of manufacturing-induced strain on drug release performance.
- To identify microstructural changes affecting drug elution in cardiac lead collars.
Main Methods:
- Utilized scanning electron microscopy, atomic force microscopy, and Raman microscopy.
- Developed a novel test fixture for simulating stresses on drug collars.
- Analyzed polydimethylsiloxane-dexamethasone acetate collars under controlled strain conditions.
Main Results:
- Identified microcracks in drug collars fitted to a rod, hypothesized to increase drug elution.
- Demonstrated that assembly strain is a critical factor in microcrack formation.
- Observed that cracks tend to form in high drug particle density areas and propagate between particles.
Conclusions:
- Assembly strain during cardiac lead collar application is a key determinant of microcrack formation.
- Microcracks in drug collars may lead to altered and potentially increased drug elution.
- Further research into manufacturing processes is needed to optimize drug release profiles.
