US2013172853A1PendingUtilityA1

Drug delivery medical device

52
Assignee: MCCLAIN JAMES BPriority: Jul 16, 2010Filed: Jul 15, 2011Published: Jul 4, 2013
Est. expiryJul 16, 2030(~4 yrs left)· nominal 20-yr term from priority
Inventors:James B. McclainCharles Douglas TaylorBrett G. ZaniJohn M. NeetTimothy Charles Kiorpes
A61L 29/16A61L 31/16A61M 25/1011A61L 31/10A61M 25/10A61L 29/085
52
PatentIndex Score
0
Cited by
0
References
0
Claims

Abstract

Provided is a coated implantable medical device, comprising: a substrate; and a coating disposed on the substrate, wherein the coating comprises at least one polymer and at least one pharmaceutical agent in a therapeutically desirable morphology and/or at least one active biological agent and optionally, one or more pharmaceutical carrying agents; wherein substantially all of pharmaceutical agent and/or active biological agent remains within the coating and on the substrate until the implantable device is deployed at an intervention site inside the body of a subject and wherein upon deployment of the medical device in the body of the subject a portion of the pharmaceutical agent and/or active biological agent is delivered at the intervention site along with at least a portion of the polymer and/or a at least a portion of the pharmaceutical carrying agents.

Claims

exact text as granted — not AI-modified
1 . A medical device comprising:
 a balloon; and   a coating on at least a portion of the balloon,   wherein the coating comprises an active agent and a binding agent, and   wherein the device releases at least 3% of the active agent to artery five minutes after expansion of the balloon in the artery in vivo.   
     
     
         2 . (canceled) 
     
     
         3 . The medical device of  claim 1 , wherein the binding agents comprises at least one of: Polyarginine, Polyarginine 9-L-pArg, DEAE-Dextran (Diethylaminoethyl cellulose-Dextran), DMAB (Didodecyldimethylammonium bromide), PEI (Polyethyleneimine), TAB (Tetradodecylammonium bromide), and DMTAB (Dimethylditetradecylammonium bromide). 
     
     
         4 . The medical device of  claim 1 , wherein the active agent is sirolimus and wherein the sirolimus has an average size of at least one of: 1.5 μm, 2.5 μm, 645 nm, and 100-200 nm. 
     
     
         5 . (canceled) 
     
     
         6 . (canceled) 
     
     
         7 . (canceled) 
     
     
         8 . The medical device of  claim 1 , wherein the coating comprised and a 10:1 ratio of the active agent to the binding agent, wherein the active agent comprises sirolimus wherein the binding agent comprises Polyarginine. 
     
     
         9 . (canceled) 
     
     
         10 . The medical device of  claim 1 , wherein at least about 3 ng/mg of active agent are found in arterial tissue 72 hours after inflation of the balloon in the artery. 
     
     
         11 . (canceled) 
     
     
         12 . (canceled) 
     
     
         13 . (canceled) 
     
     
         14 . A method comprising—providing a device comprising a balloon; and a coating on at least a portion of the balloon, wherein the coating comprises an active agent and a binding agent, and wherein the device is configured to transfer to tissue of an artery at least 3% of the active agent five minutes after inflation and expansion of the balloon in the artery in vivo. 
     
     
         15 . (canceled) 
     
     
         16 . The method of  claim 14 , wherein the binding agents comprises at least one of:
 Polyarginine, Polyarginine 9-L-pArg, DEAE-Dextran (Diethylaminoethyl cellulose-Dextran), DMAB (Didodecyldimethylammonium bromide), PEI (Polyethyleneimine), TAB (Tetradodecylammonium bromide), and DMTAB (Dimethylditetradecylammonium bromide).   
     
     
         17 . (canceled) 
     
     
         18 . The method of  claim 14 , wherein the active agent is sirolimus and wherein the sirolimus has have an average size of at least one of: 1.5 μm, 2.5 μm, 645 nm, and 100-200 nm. 
     
     
         19 . (canceled) 
     
     
         20 . (canceled) 
     
     
         21 . The method of  claim 14 , wherein the coating comprised and a 10:1 ratio of the active agent to the binding agent, wherein the active agent comprises sirolimus wherein the binding agent comprises Polyarginine. 
     
     
         22 . (canceled) 
     
     
         23 . The method of  claim 14 , comprising lyophilizing the active agent and the binding agent prior to depositing the active agent and the binding agent on the balloon. 
     
     
         24 . The method of  claim 14 , wherein at least about 3 ng/mg of active agent are found in arterial tissue 72 hours after inflation of the balloon in the artery. 
     
     
         25 . (canceled) 
     
     
         26 . (canceled) 
     
     
         27 . (canceled) 
     
     
         28 . The medical device of  claim 1 , wherein the balloon comprises an invertable portion, and wherein the coating is on an abluminal side of the invertable portion of the balloon. 
     
     
         29 . (canceled) 
     
     
         30 . (canceled) 
     
     
         31 . (canceled) 
     
     
         32 . The method of  claim 14  wherein the portion of the balloon having the coating thereon is invertable. 
     
     
         33 . (canceled) 
     
     
         34 . (canceled) 
     
     
         35 . (canceled) 
     
     
         36 . The medical device of  claim 1  comprising: a sheath over the portion of the balloon having coating thereon. 
     
     
         37 . (canceled) 
     
     
         38 . (canceled) 
     
     
         39 . The method of  claim 14  wherein the device comprises a sheath over the portion of the balloon having coating thereon. 
     
     
         40 . (canceled) 
     
     
         41 . (canceled) 
     
     
         42 . The medical device of  claim 1  comprising: an occluder configured to block the flow of bodily fluids at a treatment site during exposure of the coating to the tissue. 
     
     
         43 . (canceled) 
     
     
         44 . The medical device of  claim 42 , wherein the occluder comprises a second balloon. 
     
     
         45 . (canceled) 
     
     
         46 . The medical device of  claim 42 , wherein the balloon comprises a distal node and a proximal node, and wherein the distal node comprises the coating and wherein the proximal node comprises the occluder. 
     
     
         47 . The method of  claim 14  wherein the device comprises an occluder configured to block the flow of bodily fluids at a treatment site during exposure of the coating to the tissue. 
     
     
         48 . (canceled) 
     
     
         49 . (canceled) 
     
     
         50 . (canceled) 
     
     
         51 . (canceled) 
     
     
         52 . (canceled) 
     
     
         53 . (canceled) 
     
     
         54 . (canceled) 
     
     
         55 . The method of  claim 14 , wherein at least one of: at most 1% of coating is removed from the balloon due to tracking of the coated balloon to the treatment site, at most 5% of coating is removed from the balloon due to tracking of the coated balloon to the treatment site, at most 10% of coating is removed from the balloon due to tracking of the coated balloon to the treatment site, at most 15% of coating is removed from the balloon due to tracking of the coated balloon to the treatment site, at most 20% of coating is removed from the balloon due to tracking of the coated balloon to the treatment site, at most 25% of coating is removed from the balloon due to tracking of the coated balloon to the treatment site, and at most 30% of coating is removed from the balloon due to tracking of the coated balloon to the treatment site. 
     
     
         56 . (canceled) 
     
     
         57 . (canceled) 
     
     
         58 . (canceled) 
     
     
         59 . (canceled)

Cited by (0)

No later patents cite this yet.

References (0)

No backward citations on record.