DRUG DELIVERY MEDICAL DEVICE
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.
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)