US 2010.0015200A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2010/0015200 A1 McClain et al. (43) Pub. Date: Jan. 21, 2010 (54) DRUG DELIVERY MEDICAL DEVICE A638/19 (2006.01) A638/18 (2006.01) (75) Inventors: James B. McClain, Raleigh, NC A63L/7088 (2006.01) (US); Douglas Taylor, Franklinton, A 6LX 3L/705 (2006.01) NC (US); John Neet, Lawrence, KS A6II 3L/20 (2006.01) (US) A 6LX 3L/75 (2006.01) A6II 35/12 (2006.01) Correspondence Address: A6IR 48/00 (2006.01) WILSON, SONSINI, GOODRICH & ROSATI 650 PAGE MILL ROAD (52) U.S. Cl. .............. 424/423: 514/12: 424/94.1: 514/8: PALO ALTO, CA 94304-1050 (US) 514/44 R: 514/44 A: 514/558: 514/169: 514/54; 424.793.7 (73) Assignee: MICELL TECHNOLOGIES, INC., Raleigh, NC (US) (57) ABSTRACT (21) Appl. No.: 12/504,597 Provided is a coated implantable medical device, comprising: a Substrate; and a coating disposed on said Substrate, wherein (22) Filed: Jul. 16, 2009 said coating comprises at least one polymer and at least one pharmaceutical agent in a therapeutically desirable morphol Related U.S. Application Data ogy and/or at least one active biological agent and optionally, one or more pharmaceutical carrying agents; wherein Sub (60) Provisional application No. 61/081.691, filed on Jul. stantially all of pharmaceutical agent and/or active biological 17, 2008, provisional application No. 61/212.964, agent remains within said coating and on said Substrate until filed on Apr. 17, 2009. the implantable device is deployed at an intervention site O O inside the body of a subject and wherein upon deplowment of Publication Classification said medical i.e. in E. body of said E. EN of (51) Int. Cl. said pharmaceutical agent and/or active biological agent is A6F 2/02 (2006.01) delivered at said intervention site along with at least a portion A6K 38/17 (2006.01) of said polymer and/ora at least a portion of said pharmaceu A6 IK 38/43 (2006.01) tical carrying agents. US 2010/0015200 A1 Jan. 21, 2010 DRUG DELVERY MEDICAL DEVICE the device is adapted to free greater than 35% of the coating from the Substrate upon a single stimulation of the coating. CROSS-REFERENCE 0010 Provided herein is a medical device comprising a 0001. This application claims the benefit of U.S. Provi Substrate and a coating on at least a portion of said Substrate, sional Application No. 61/081.691, filed Jul. 17, 2008, and wherein said coating comprises an active agent, and wherein U.S. Provisional Application No. 61/212.964, filed Apr. 17. the device is adapted to dissociate greater than 35% of the 2009, which applications are incorporated herein by refer coating from the Substrate upon a single stimulation of the ence in their entirety. coating. 0011 Provided herein is a medical device comprising a BACKGROUND OF THE INVENTION Substrate and a coating on at least a portion of said Substrate, wherein said coating comprises an active agent, and wherein 0002 There is a need for medical device technology that the device is adapted to transfer greater than 35% of the can rapidly, efficiently, reproducibly and safely transfer a coating from the Substrate to an intervention site upon a single Drug Delivery Formulation from the surface of a percutane stimulation of the coating. ous medical device (a coating) onto/into a specific site in the 0012 Provided herein is a medical device comprising a body. Substrate and a coating on at least a portion of said Substrate, wherein said coating comprises an active agent, wherein the SUMMARY OF THE INVENTION coating is patterned, and wherein at least a portion of the 0003 Provided herein is a medical device comprising a coating is adapted to free from the Substrate upon stimulation Substrate and a coating on at least a portion of the Substrate, of the coating. wherein the coating comprises a plurality of layers, wherein 0013 Provided herein is a medical device comprising a at least one layer comprises a pharmaceutical agent that is Substrate and a coating on at least a portion of said Substrate, crystalline, and wherein the device is adapted to free at least wherein said coating comprises an active agent, wherein the a portion of the coating from the Substrate upon stimulation of coating is patterned, and wherein at least a portion of the the coating. coating is adapted to dissociate from the Substrate upon 0004 Provided herein is a medical device comprising a stimulation of the coating. Substrate and a coating on at least a portion of the Substrate, 0014 Provided herein is a medical device comprising a wherein the coating comprises a plurality of layers, wherein Substrate and a coating on at least a portion of said Substrate, at least one layer comprises a pharmaceutical agent that is wherein said coating comprises an active agent, wherein the crystalline, and wherein the device is adapted to dissociate at coating is patterned, and wherein at least a portion of the least a portion of the coating from the Substrate upon stimu coating is adapted to transfer from the Substrate to an inter lation of the coating. vention site upon stimulation of the coating. 0005 Provided herein is a medical device comprising a 0015. In some embodiments, the therapeutically desirable Substrate and a coating on at least a portion of said Substrate, morphology comprises a crystalline form of the pharmaceu wherein the coating comprises a plurality of layers, wherein tical agent that is not a microcapsule. at least one layer comprises a pharmaceutical agent that is 0016. In some embodiments, the single stimulation lasts at crystalline, and wherein the device is adapted to transfer at most 20 seconds. In some embodiments, the device is adapted least a portion of the coating from the Substrate to an inter to free Substantially all of the coating upon the single stimu vention site upon stimulation of the coating. lation of the coating. In some embodiments, the single stimu 0006 Provided herein is a medical device comprising a lation lasts at most 20 seconds. In some embodiments, Sub Substrate and a coating on at least a portion of said Substrate, stantially all of the coating frees from the substrate wherein said coating is at least partially continuous, has at instantaneously upon stimulation of the coating. least one portion conformal to the Substrate, and comprises a 0017. In some embodiments, the patterned coating com pharmaceutical agent that is crystalline, and wherein the prises at least two different shapes. device is adapted to free at least a portion of the coating from 0018 Provided herein is a medical device comprising: a the Substrate upon stimulation of the coating. Substrate; and a coating on at least a portion of said Substrate, 0007 Provided herein is a medical device comprising:a wherein said coating comprises an active agent, and wherein Substrate and a coating on at least a portion of said Substrate, at least a portion of the coating is adapted to transfer from the wherein said coating is at least partially continuous, has at Substrate to an intervention site. In some embodiments, the least one portion conformal to the Substrate, and comprises a portion of the coating is adapted to transfer from the Substrate pharmaceutical agent that is crystalline, and wherein the to the intervention site upon stimulation of the coating. device is adapted to dissociate at least a portion of the coating 0019 Provided herein is a medical device comprising: a from the Substrate upon stimulation of the coating. Substrate; and a coating on at least a portion of said Substrate, 0008 Provided herein is a medical device comprising a wherein said coating comprises an active agent, and wherein Substrate and a coating on at least a portion of said Substrate, at least a portion of the active agent is adapted to transfer from wherein said coating is at least partially continuous, has at the Substrate to an intervention site. In some embodiments, least one portion conformal to the Substrate, and comprises a the portion of the active agent is adapted to transfer from the pharmaceutical agent that is crystalline, and wherein the substrate to the intervention site upon stimulation of the coat device is adapted to transfer at least a portion of the coating ing. from the Substrate to an intervention site upon stimulation of 0020 Provided herein is a medical device comprising: a the coating. Substrate; and a coating on at least a portion of said Substrate, 0009 Provided herein is a medical device comprising a wherein said coating comprises an active agent, and wherein Substrate and a coating on at least a portion of said Substrate, the device is adapted to transfer at least a portion of the wherein said coating comprises an active agent, and wherein coating from the Substrate to an intervention site. In some US 2010/0015200 A1 Jan. 21, 2010 embodiments, the device is adapted to transfer the portion of 0027. In some embodiments of the methods and/or the coating (coating portion) from the Substrate to the inter devices provided herein, the balloon is a compliant balloon. vention site upon stimulation of the coating. In some embodiments, the balloon is a semi-compliant bal 0021 Provided herein is a medical device comprising: a loon. In some embodiments, the balloon is a non-compliant Substrate; and a coating on at least a portion of said Substrate, balloon. In some embodiments, the balloon conforms to a wherein said coating comprises an active agent, and wherein shape of the intervention site.