Evaluation of Tissue Interactions with Mechanical Elements of a Transscleral Drug Delivery Device.docVIP

Pharmaceutics 2012, 4, 212-229; doi:10.3390/pharmaceutics4010212 OPEN ACCESS pharmaceutics ISSN 1999-4923 /journal/pharmaceutics Article Evaluation of Tissue Interactions with Mechanical Elements of a Transscleral Drug Delivery Device Sarah J. Cohen 1, Robison V. Paul Chan 2, Mark Keegan 1, Christopher M. Andreoli 2, Jeffrey T. Borenstein 1,*, Joan W. Miller 2 and Evangelos S. Gragoudas 2 1 Charles Stark Draper Laboratory, 555 Technology Square, Cambridge, MA 02139, USA; E-Mails: sjcohen@ (S.J.C.); mek10@ (M.K.) 2 Massachusetts Eye and Ear Infirmary, 243 Charles Street, Boston, MA 02114, USA; E-Mails: roc9013@ (R.V.P.C.); christopher_andreoli@ (C.M.A.); joan_miller@ (J.W.M.); evangelos_gragoudas@ (E.S.G.) * Author to whom correspondence should be addressed; E-Mail: jborenstein@; Tel.: +1-617-258-1686; Fax: +1-617-258-1131. Received: 13 February 2012; in revised form: 29 February 2012 / Accepted: 29 February 2012 / Published: 12 March 2012 Abstract: The goal of this work was to evaluate tissue-device interactions due to implantation of a mechanically operated drug delivery system onto the posterior sclera. Two test devices were designed and fabricated to model elements of the drug delivery device—one containing a free-spinning ball bearing and the other encasing two articulating gears. Openings in the base of test devices modeled ports for drug passage from device to sclera. Porous poly(tetrafluoroethylene) (PTFE) membranes were attached to half of the gear devices to minimize tissue ingrowth through these ports. Test devices were sutured onto rabbit eyes for 10 weeks. Tissue-device interactions were evaluated histologically and mechanically after removal to determine effects on device function and changes in surrounding tissue. Test devices were generally well-tolerated during residence in the animal. All devices encouraged fibrous tissue formation between the sclera and the device, f