US6358556B1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Drug release stent coating
Assignee: Boston Scientific Corp
•
Filing: 1998-01-23
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Granted: 2002-03-19
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Expires: 2018-01-23
Abstract
Abstract A method of coating implantable open lattice metallic stent prosthesis is disclosed which includes sequentially applying a plurality of relatively thin outer layers of a coating composition comprising a solvent mixture of uncured polymeric silicone material and crosslinker and finely divided biologically active species, possibly of controlled average particle size, to form a coating on each stent surface. The coatings are cured in situ and the coated, cured prosthesis are sterilized in a step that includes preferred pretreatment with argon gas plasma and exposure to gamma radiation electron beam, ethylene oxide, steam.
Inventors
- 👤 Ni Ding
- 👤 Michael N. Helmus
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 15:57
CPC Classifications
A; A61; A61L; A61L31/00; A61L31/14; A61L31/16; A61F; A61F2/00; A61F2/82; A61F2/86; A61F2/90; A61L27/00; A61L27/14; A61L27/22; A61L27/227; A61L31/08; A61L31/10; A61L31/141; A61L33/00; A61L33/0005; A61L33/0011; A61F2210/00; A61F2210/0014; A61F2250/00; A61F2250/0058; A61F2250/0067; A61L2300/00; A61L2300/20; A61L2300/22; A61L2300/222; A61L2300/23; A61L2300/236; A61L2300/40; A61L2300/404; A61L2300/406; A61L2300/42; A61L2300/60; A61L2300/602; A61L2300/606; A61L2300/608; A61L2300/62; A61L2300/622; A61L2420/00; A61L2420/02
Claims Analysis
Total Claims: 24
Claim 1
Independent Claim
83 words
A process for making an implantable medical prosthesis in which at least a portion of the prosthesis is covered with a coating, wherein the process comprises: (a) applying a composition, comprising a polymeric material incorporating a biologically active material, to the portion of the prosthesis to form a coating thereon; (b) curing the coating; (c) exposing the portion of the prosthesis to an inert gas plasma treatment after the coating is cured; and (d) sterilizing the portion of the prosthesis with gamma radiation.
Claim 2
Dependent Claim
83 words
A process for making an implantable medical prosthesis in which at least a portion of the prosthesis is covered with a coating, wherein the process comprises: (a) applying a composition, comprising a polymeric material incorporating a biologically active material, to the portion of the prosthesis to form a coating thereon; (b) curing the coating; (c) exposing the portion of the prosthesis to an inert gas plasma treatment after the coating is cured; and (d) sterilizing the portion of the prosthesis with gamma radiation.
Claim 3
Dependent Claim
21 words
The process of claim 1 wherein the inert gas is selected from the group consisting of argon, helium or mixtures thereof.
Claim 4
Dependent Claim
11 words
The process of claim 2 wherein the inert gas is argon.
Claim 5
Dependent Claim
27 words
The process of claim 1 wherein the portion of the prosthesis is exposed to the inert gas plasma treatment for about 30 seconds to about 5 minutes.
Claim 6
Dependent Claim
23 words
The process of claim 4 wherein the portion of the prosthesis is exposed to the inert gas for an additional period of time.
Claim 7
Dependent Claim
15 words
The process of claim 5 wherein the additional period of time is about 5 minutes.
Claim 8
Dependent Claim
16 words
The process of claim 1 wherein the gamma radiation is about 2.5 to about 3.5 Mrad.
Claim 9
Dependent Claim
34 words
The process of claim 1 wherein the coating is cured by a method selected from the group consisting of applying a heat source to the coating and applying a chemical agent to the coating.
Claim 10
Dependent Claim
24 words
The process of claim 1 wherein the biologically active material has an average particle size of equal to or less than about 15 μm.
Claim 11
Dependent Claim
24 words
The process of claim 9 wherein the biologically active material has an average particle size of equal to or less than about 10 μm.
Claim 12
Dependent Claim
44 words
The process of claim 9 wherein the coating reduces an initial burst release of the biologically active material upon implantation of the prosthesis as compared to a coating comprising the same biologically active material having an average particle size greater than about 15 μm.
Claim 13
Dependent Claim
18 words
The process of claim 1 wherein the composition comprises about 25-45 weight percent of the biologically active material.
Claim 14
Dependent Claim
12 words
The process of claim 1 wherein the biologically active material includes heparin.
Claim 15
Dependent Claim
14 words
The process of claim 1 wherein the polymeric material is a hydrophobic elastomeric material.
Claim 16
Dependent Claim
33 words
The process of claim 14 wherein the hydrophobic elastomeric material is selected from the group consisting of silicones, polyurethanes, polyamide elastomers, ethylene vinyl acetate copolymers, polyolefin elastomers, ethylene-propylene terpolymer rubbers and combinations thereof.
Claim 17
Dependent Claim
59 words
The process of claim 14 wherein the prosthesis is an expandable stent having a tubular metal body having open ends and a sidewall structure having openings therein and wherein the composition is applied to the stent in a manner such that the composition adheringly conforms to the sidewall structure to preserve the openings therein when the stent is expanded.
Claim 18
Dependent Claim
13 words
An implantable medical prosthesis prepared according to the process of claim 1 .
Claim 19
Dependent Claim
12 words
The process of claim 1 Wherein the prosthesis is an expandable stent.
Claim 20
Dependent Claim
11 words
The process of claim 18 wherein the expandable stent is self-expanding.
Claim 21
Dependent Claim
82 words
A process for making an expandable stent in which at least a portion of the stent is covered with a coating, wherein the process comprises: (a) applying a composition, comprising a hydrophobic elastomeric material incorporating a biologically active material, to the portion of the stent to form a coating thereon; (b) curing the coating; (c) exposing the portion of the stent to an argon plasma treatment after the coating is cured; and (d) sterilizing the portion of the stent with gamma radiation.
Claim 22
Dependent Claim
82 words
A process for making an expandable stent in which at least a portion of the stent is covered with a coating, wherein the process comprises: (a) applying a composition, comprising a hydrophobic elastomeric material incorporating a biologically active material, to the portion of the stent to form a coating thereon; (b) curing the coating; (c) exposing the portion of the stent to an argon plasma treatment after the coating is cured; and (d) sterilizing the portion of the stent with gamma radiation.
Claim 23
Dependent Claim
96 words
A process for making an expandable stent in which at least a portion of the stent is covered with a coating, wherein the process comprises: (a) applying a composition, comprising a polymeric material incorporating a biologically active material, to the portion of the stent to form a coating thereon; (b) curing the coating; (c) exposing the portion of the stent to an argon plasma treatment for about 30 seconds to about 5 minutes after the coating is cured; and (d) sterilizing the portion of the stent with gamma radiation of about 2.5 to about 3.4 Mrad.
Claim 24
Dependent Claim
96 words
A process for making an expandable stent in which at least a portion of the stent is covered with a coating, wherein the process comprises: (a) applying a composition, comprising a polymeric material incorporating a biologically active material, to the portion of the stent to form a coating thereon; (b) curing the coating; (c) exposing the portion of the stent to an argon plasma treatment for about 30 seconds to about 5 minutes after the coating is cured; and (d) sterilizing the portion of the stent with gamma radiation of about 2.5 to about 3.4 Mrad.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2005-03-18 | 2005-09-17 | 2006-03-19 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2009-03-18 | 2009-09-17 | 2010-03-19 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2013-03-18 | 2013-09-17 | 2014-03-19 | $7700.00 | Window Closed / Lapsed |