Patent US6335029B1 successfully refreshed from Google Patents.
US6335029B1
Expired / Lapsed
US
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Polymeric coatings for controlled delivery of active agents
Assignee: Boston Scientific Corp
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Filing: 1998-12-03
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Granted: 2002-01-01
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Expires: 2018-12-03
Abstract
Abstract Implantable medical device having a structure adapted for introduction into a patient wherein the structure is composed of a base material positioned over the structure. The implantable medical device further includes at least one composite layer of a bioactive agent and a polymer material and at least a barrier layer positioned over the composite layer and being of thickness adequate to provide a controlled release of the bioactive agent. The barrier layer being applied by a low energy plasma polymerization process which includes placing the device with the at least one composite layer in a plasma chamber and introducing at least one monomer gas.
Inventors
- 👤 Kalpana R. Kamath
- 👤 James J. Barry
- 👤 Sepideh H. Nott
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 13:29
CPC Classifications
A; A61; A61L; A61L31/00; A61L31/14; A61L31/16; A61L27/00; A61L27/28; A61L27/34; A61L27/50; A61L27/54; A61L29/00; A61L29/08; A61L29/085; A61L29/14; A61L29/16; A61L31/08; A61L31/10; A61P; A61P35/00; B; B05; B05D; B05D1/00; B05D1/60; A61L2300/00; A61L2300/40; A61L2300/416; A61L2300/60; A61L2300/602; A61L2300/606; A61L2300/608
Claims Analysis
Total Claims: 15
Claim 1
Independent Claim
107 words
An implantable medical device comprising: a structure adapted for introduction into a patient, wherein the structure comprises a base material; at least one layer comprised of at least one bioactive agent in a polymer matrix, applied to at least a portion of the outer surface of said base material; and at least one barrier layer positioned over the layer comprised of at least one bioactive agent in a polymer matrix, said barrier layer having a thickness adequate to provide controlled release of the at least one bioactive agent; wherein said barrier layer is formed in situ by a low energy plasma polymerization process of a monomer gas.
Claim 2
Dependent Claim
107 words
An implantable medical device comprising: a structure adapted for introduction into a patient, wherein the structure comprises a base material; at least one layer comprised of at least one bioactive agent in a polymer matrix, applied to at least a portion of the outer surface of said base material; and at least one barrier layer positioned over the layer comprised of at least one bioactive agent in a polymer matrix, said barrier layer having a thickness adequate to provide controlled release of the at least one bioactive agent; wherein said barrier layer is formed in situ by a low energy plasma polymerization process of a monomer gas.
Claim 3
Dependent Claim
50 words
The implantable device of claim 1 , wherein said polymer material comprises a polymer selected from the group consisting of polyurethane, polycarboxylic acids, polyorthoesters, polyvinylpyrrolidone, maleic anhydride polymers, polyamides, polyvinyl alcohols, polyethylene oxides, glycosaminoglycans, proteins, polypeptides, silicones, polysaccharides, polyesters, polyacrylamides, polyethers, copolymers of vinyl monomers, and mixtures and copolymers thereof.
Claim 4
Dependent Claim
15 words
The device of claim 1 , wherein said at least one bioactive agent is paclitaxel.
Claim 5
Dependent Claim
21 words
The device of claim 1 , wherein the thickness of said at least one barrier layer is less than 5000 Å.
Claim 6
Dependent Claim
22 words
The device of claim 4 , wherein the thickness of said at least one barrier layer is about 50 to 2000 Å.
Claim 7
Dependent Claim
48 words
The device of claim 1 , wherein the medical device is a device selected from the group consisting of a catheter, wire guide, cannula, stent graft, covered stent, vascular or other graft, cardiac pacemaker lead or lead tip; an angioplasty device or portion thereof; and any portion thereof.
Claim 8
Dependent Claim
21 words
The device of claim 1 , wherein the base material of the structure comprises at least one of metal or polymer.
Claim 9
Dependent Claim
42 words
The device of claim 1 , wherein said monomer gas is selected from the group consisting of a cyclic or acyclic siloxane silicon-based monomers, silane silicon-based monomers, silylimidazoles silicon-based monomers, hydrofluorocarbon-based monomers; aliphatic or aromatic hydrocarbon-based monomer; acrylic monomer; and combinations thereof.
Claim 10
Dependent Claim
15 words
The device of claim 1 , further comprising a drug layer over said barrier layer.
Claim 11
Dependent Claim
12 words
The device of claim 4 , wherein said drug layer includes heparin.
Claim 12
Independent Claim
192 words
A method for the localized delivery of a drug agent to a target location within a body, comprising the steps of: A) providing an implantable medical device which comprises a coated structure adapted for introduction into a patient, the structure comprising: (a) a base material; (b) at least one layer comprised of at least one bioactive agent in a polymer matrix, applied to at least a portion of the outer surface of said base material; B) forming at least one barrier layer comprising a polymer over the layer comprised of at least one bioactive agent in a polymer matrix, wherein said at least one barrier layer has a thickness adequate to provide a controlled release of the at least one bioactive agent, wherein said barrier layer is applied by a low energy plasma polymerization process which comprises: (i) placing said coated structure in a chamber; (ii) introducing at least one monomer gas into said chamber; and (iii) exposing the gas to a low energy source, whereby the monomer gas forms a barrier layer on the outer surface of the medical device; and C) delivering said implantable medical device to said target location.
Claim 13
Independent Claim
192 words
A method for the localized delivery of a drug agent to a target location within a body, comprising the steps of: A) providing an implantable medical device which comprises a coated structure adapted for introduction into a patient, the structure comprising: (a) a base material; (b) at least one layer comprised of at least one bioactive agent in a polymer matrix, applied to at least a portion of the outer surface of said base material; B) forming at least one barrier layer comprising a polymer over the layer comprised of at least one bioactive agent in a polymer matrix, wherein said at least one barrier layer has a thickness adequate to provide a controlled release of the at least one bioactive agent, wherein said barrier layer is applied by a low energy plasma polymerization process which comprises: (i) placing said coated structure in a chamber; (ii) introducing at least one monomer gas into said chamber; and (iii) exposing the gas to a low energy source, whereby the monomer gas forms a barrier layer on the outer surface of the medical device; and C) delivering said implantable medical device to said target location.
Claim 14
Dependent Claim
26 words
The method of claim 11 , further comprising the step of introducing additional bioactive agent into said at least one barrier layer by a dipping process.
Claim 15
Dependent Claim
17 words
A method according to claim 11 , wherein the low energy source is low energy radio frequency.
References Cited (Backward Citations)
WO1995013313A1
Cited
US5869127A
Cited
US5609629A
Cited
WO1997038801A1
Cited
WO1998035784A1
Cited
WO1998036784A1
Cited
WO1999000071A1
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2004-12-31 | 2005-07-02 | 2006-01-01 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-12-31 | 2009-07-02 | 2010-01-01 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-12-31 | 2013-07-02 | 2014-01-01 | $7700.00 | Window Closed / Lapsed |