NMP 2008

JEANETTE POLKINGHORNE

Boston Scientific and
Characterization Facility
University of Minnesota


PROBING THE DRUG RELEASE PROFILE OF A DRUG-ELUTING MEDICAL DEVICE

 

Jeannette Polkinghorne
Boston Scientific
Jinping Dong (Characterization Facility), Dean Poppe (CEMS)


Cardiac leads, which connect medical devices such as pacemakers and defibrillators to the heart, are used to monitor the heart’s rhythm and provide therapy when needed. A drug delivery system is incorporated onto the end of cardiac leads to reduce inflammation and fibrosis at the lead-tissue interface and enables optimal lead performance. In this research, confocal Raman microscopy is used to capture images of the drug delivery system at different time points and in different elution media.

Raman scattering provides chemical fingerprints of a material irradiated by a laser. Combing high resolution confocal optical microscopy and Raman spectroscopy, a 3-D chemical map can be obtained from a material with the ultimate resolution of 2-300 nm laterally and ~500 nm vertically. The Raman images show that the drug (dexamethasone acetate) forms 1-3um sized particles in the silicone matrix of the lead collar. Upon being immersed in a methanol solution for 1 hour, a majority of the drug was eluted to a depth extending to tens of microns. Holes were left within the silicone matrix; the number and size of the holes do not match with the drug domains before elution which suggests a potential complex drug release process. This research provides insight into the mechanism of release to help guide design of refined devices for human use.