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US6099562A Expired / Lapsed US ⏱️ 0.0 years remaining

Drug coating with topcoat

Assignee: Boston Scientific Scimed Inc
•
Filing: 1997-12-22
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Granted: 2000-08-08
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Expires: 2017-12-22
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Abstract

Abstract A coating and method for a coating an implantable device or prostheses are disclosed. The coating includes an undercoat of polymeric material containing an amount of biologically active material, particularly heparin, dispersed therein. The coating further includes a topcoat which covers less than the entire surface of the undercoat and wherein the topcoat comprises a polymeric material substantially free of pores and porosigens. The polymeric material of the topcoat can be a biostable, biocompatible material which provides long term non-thrombogenicity to the device portion during and after release of the biologically active material.

Inventors

  • 👤 Ni Ding
  • 👤 Michael N. Helmus

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 03:42
CPC Classifications
A; A61; A61L; A61L33/00; A61L33/0005; A61L33/0011; A61F; A61F2/00; A61F2/82; A61F2/86; A61F2/90; A61L27/00; A61L27/14; A61L27/22; A61L27/227; A61L31/00; A61L31/08; A61L31/10; A61L31/14; A61L31/141; A61L31/16; A61F2210/00; A61F2210/0014; A61F2250/00; A61F2250/0058; A61F2250/0067; A61L2300/00; A61L2300/20; A61L2300/23; A61L2300/236; A61L2300/40; A61L2300/404; A61L2300/406; A61L2300/416; A61L2300/42; A61L2300/60; A61L2300/602; A61L2300/606; A61L2300/608; A61L2420/00; A61L2420/08

Claims Analysis

Total Claims: 29
Claim 1
Independent Claim 116 words
A medical device having at least a portion which is implantable into the body of a patient, wherein at least a part of the device portion is covered with a coating for release of at least one biologically active material, wherein said coating comprises an undercoat having an outer surface and comprising a polymeric material incorporating an amount of biologically active material therein for timed release therefrom, and wherein said coating further comprises a topcoat formed of a discontinuous coating being disposed over the entire outer surface of the undercoat, thereby forming covered and uncovered areas of the undercoat throughout the entire outer surface, said topcoat comprising a polymeric material substantially free of pores and porosigens.
Claim 2
Dependent Claim 116 words
A medical device having at least a portion which is implantable into the body of a patient, wherein at least a part of the device portion is covered with a coating for release of at least one biologically active material, wherein said coating comprises an undercoat having an outer surface and comprising a polymeric material incorporating an amount of biologically active material therein for timed release therefrom, and wherein said coating further comprises a topcoat formed of a discontinuous coating being disposed over the entire outer surface of the undercoat, thereby forming covered and uncovered areas of the undercoat throughout the entire outer surface, said topcoat comprising a polymeric material substantially free of pores and porosigens.
Claim 3
Dependent Claim 19 words
The device of claim 1 wherein the topcoat covers less than the entire undercoat while the device is implanted.
Claim 4
Dependent Claim 19 words
The device of claim 1 wherein the topcoat covers less than the entire undercoat before the device is implanted.
Claim 5
Dependent Claim 25 words
The device of claim 1 wherein the topcoat covers less than the entire undercoat before the device is implanted and while the device is implanted.
Claim 6
Dependent Claim 48 words
The device of claim 1 wherein the polymeric material of the undercoat is a hydrophobic elastomeric material and wherein the polymeric material of the topcoat is a biostable, biocompatible material which provides long term non-thrombogenicity to the device portion during and after release of the biologically active material.
Claim 7
Dependent Claim 26 words
The device of claim 1 wherein the topcoat reduces a burst release of the biologically active material as compared to a coated device without the topcoat.
Claim 8
Dependent Claim 12 words
The device of claim 1 wherein the biologically active material is heparin.
Claim 9
Dependent Claim 28 words
The device of claim 1 wherein the polymeric material of the topcoat is selected from the group consisting of fluorosilicone, polyethylene glycol (PEG), polysaccharides, phospholipids and combinations thereof.
Claim 10
Dependent Claim 11 words
The device of claim 8 wherein the polymeric material is fluorosilicone.
Claim 11
Dependent Claim 13 words
The device of claim 8 wherein the polymeric material is polyethylene glycol (PEG).
Claim 12
Dependent Claim 20 words
The device of claim 1 wherein the topcoat covers from about 5% to 95% of the surface of the undercoat.
Claim 13
Dependent Claim 20 words
The device of claim 11 wherein the topcoat covers from about 20% to 85% of the surface of the undercoat.
Claim 14
Dependent Claim 18 words
The device of claim 1 wherein the topcoat has an average thickness of about 1 to 7 microns.
Claim 15
Dependent Claim 18 words
The device of claim 13 wherein the topcoat has an average thickness of about 1 to 5 microns.
Claim 16
Dependent Claim 23 words
The device of claim 1 wherein the topcoat has an average thickness of about the average particle size of the biologically active material.
Claim 17
Dependent Claim 12 words
The device of claim 1 wherein the device is an expandable stent.
Claim 18
Dependent Claim 19 words
The device of claim 1 wherein the polymeric materials of the topcoat and the bottom coat are water permeable.
Claim 19
Independent Claim 161 words
A method of using an implantable stent prosthesis comprising: (a) providing an implantable stent prosthesis having at least a portion which is implantable into the body of a patient, wherein at least a part of the device portion is covered with a coating for release of at least one biologically active material, wherein said coating comprises an undercoat having an outer surface and comprising a polymeric material incorporating an amount of biologically active material therein for timed release therefrom, and wherein said coating further comprises a topcoat formed of a discontinuous coating being disposed over the entire outer surface of the undercoat, thereby forming covered and uncovered areas of the undercoat throughout the entire outer surface, said topcoat comprising a polymeric material substantially free of pores and porosigens; (b) implanting the device into the body of a patient; and (c) allowing the biologically active material to be released such that the topcoat limits the burst release of the biologically active material.
Claim 20
Independent Claim 161 words
A method of using an implantable stent prosthesis comprising: (a) providing an implantable stent prosthesis having at least a portion which is implantable into the body of a patient, wherein at least a part of the device portion is covered with a coating for release of at least one biologically active material, wherein said coating comprises an undercoat having an outer surface and comprising a polymeric material incorporating an amount of biologically active material therein for timed release therefrom, and wherein said coating further comprises a topcoat formed of a discontinuous coating being disposed over the entire outer surface of the undercoat, thereby forming covered and uncovered areas of the undercoat throughout the entire outer surface, said topcoat comprising a polymeric material substantially free of pores and porosigens; (b) implanting the device into the body of a patient; and (c) allowing the biologically active material to be released such that the topcoat limits the burst release of the biologically active material.
Claim 21
Dependent Claim 19 words
The method of claim 18 wherein the topcoat remains on the undercoat after release of the biologically active material.
Claim 22
Dependent Claim 19 words
The method of claim 18 wherein the topcoat covers less than the entire undercoat while the device is implanted.
Claim 23
Dependent Claim 19 words
The method of claim 18 wherein the topcoat covers less than the entire undercoat before the device is implanted.
Claim 24
Dependent Claim 25 words
The method of claim 18 wherein the topcoat covers less than the entire undercoat before the device is implanted and while the device is implanted.
Claim 25
Dependent Claim 48 words
The method of claim 18 wherein the polymeric material of the undercoat is a hydrophobic elastomeric material and wherein the polymeric material of the topcoat is a biostable, biocompatible material which provides long term non-thrombogenicity to the stent portion during and after release of the biologically active material.
Claim 26
Dependent Claim 28 words
The method of claim 18 wherein the polymeric material of the topcoat is selected from the group consisting of fluorosilicone, polyethylene glycol (PEG), polysaccharides, phospholipids and combinations thereof.
Claim 27
Dependent Claim 20 words
The method of claim 18 wherein the topcoat covers from about 5% to 95% of the surface of the undercoat.
Claim 28
Dependent Claim 23 words
The method of claim 18 wherein the topcoat has an average thickness of about the average particle size of the biologically active material.
Claim 29
Dependent Claim 18 words
The method of claim 18 wherein the topcoat has an average thickness of about 1 to 7 microns.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2003-08-08 2004-02-07 2004-08-08 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2007-08-08 2008-02-07 2008-08-08 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2011-08-08 2012-02-07 2012-08-08 $7700.00 Window Closed / Lapsed

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