US6099561A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Vascular and endoluminal stents with improved coatings
Assignee: Boston Scientific Scimed Inc
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Filing: 1998-10-20
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Granted: 2000-08-08
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Expires: 2018-10-20
Abstract
Abstract A vascular or endoluminal stent is adapted for deployment in a vessel or tract of a patient to maintain an open lumen therein. The stent includes a biocompatible metal hollow tube constituting a base layer having a multiplicity of openings through an open-ended tubular wall thereof, the tube constituting a single member from which the entire stent is fabricated, and a thin, tightly adherent intermediate layer of noble metal overlying the entire exposed surface area of the tube including edges of the openings as well as exterior and interior surfaces and ends of the wall. A third, outermost ceramic-like layer composed of an oxide, hydroxide or nitrate of a noble metal is formed atop and in adherent relation to the intermediate layer.
Inventors
- 👤 Eckhard Alt
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 15:02
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/82; A61F2/86; A61F2/90; A61F2/91; A61F2/915; A61F2002/91533; A61F2002/91541; A61F2002/9155; A61F2002/91558; A61F2210/00; A61F2210/0076; A61F2210/0095; A61F2240/00; A61F2240/001; A61F2310/00; A61F2310/00389; A61F2310/00395; A61F2310/00419; A61F2310/00568; A61F2310/00592; A61F2310/00598; A61F2310/00856; A61F2310/0088
Claims Analysis
Total Claims: 44
Claim 1
Independent Claim
137 words
A vascular or endoluminal stent adapted to be implanted in a selected vessel, duct or tract of a human body to maintain an open lumen at the site of the implant, comprising a biocompatible metal hollow tube having a multiplicity of openings through an open-ended tubular sidewall thereof as a base layer which is biologically compatible with the blood and tissue of the human body, said tube constituting a single member from which the entire stent is fabricated; a thin, tightly adherent intermediate layer of a noble metal of substantially greater radiopacity than the base layer overlying the entire exposed surface area of said tube including edges of said openings as well as exterior and interior surfaces and ends of said sidewall; and a highly biocompatible ceramic-like metal outermost layer adherent to and overlying said intermediate layer.
Claim 2
Dependent Claim
137 words
A vascular or endoluminal stent adapted to be implanted in a selected vessel, duct or tract of a human body to maintain an open lumen at the site of the implant, comprising a biocompatible metal hollow tube having a multiplicity of openings through an open-ended tubular sidewall thereof as a base layer which is biologically compatible with the blood and tissue of the human body, said tube constituting a single member from which the entire stent is fabricated; a thin, tightly adherent intermediate layer of a noble metal of substantially greater radiopacity than the base layer overlying the entire exposed surface area of said tube including edges of said openings as well as exterior and interior surfaces and ends of said sidewall; and a highly biocompatible ceramic-like metal outermost layer adherent to and overlying said intermediate layer.
Claim 3
Dependent Claim
20 words
The stent of claim 1, wherein the overall thickness of the sidewall is less than or equal to 50 μm.
Claim 4
Dependent Claim
37 words
The stent of claim 1, wherein the outermost layer has a rough outer surface for retention of drugs to be time released therefrom after the stent is implanted, to assist the stent in maintaining said lumen open.
Claim 5
Dependent Claim
14 words
The stent of claim 3, wherein said outermost layer is composed of iridium oxide.
Claim 6
Dependent Claim
50 words
The stent of claim 3, wherein the sidewall has an outward facing surface, an inward facing surface, and edges along holes through the sidewall and the open ends thereof, and said drug-retention outer surface is present along at least one of said outward facing surface and said inward facing surface.
Claim 7
Dependent Claim
23 words
The stent of claim 3, wherein said outermost layer has a thickness in a range from about 500 nm to about 1500 nm.
Claim 8
Dependent Claim
28 words
The stent of claim 1, wherein said intermediate layer is composed of gold with a substantially uniform thickness in a range from about 3 to about 6 μm.
Claim 9
Dependent Claim
28 words
The stent of claim 1, wherein at least one drug selected from a group consisting of anti-thrombotic, anti-platelet, anti-inflammatory and anti-proliferative drugs is present on said outermost layer.
Claim 10
Dependent Claim
23 words
The stent of claim 8, wherein said at least one drug is incorporated in a biodegradable material for timed release of the drug.
Claim 11
Dependent Claim
44 words
The stent of claim 1, wherein a viral vector is present on said outermost layer and selected for transfer of genetic information to target cells in tissue at the inner lining of said vessel, duct or tract to inhibit proliferation of tissue growth thereat.
Claim 12
Dependent Claim
15 words
The stent of claim 10, wherein said viral vector is incorporated in a biodegradable material.
Claim 13
Dependent Claim
27 words
The stent of claim 5, wherein an anti-thrombotic drug is present on said inward facing surface, and an anti-inflammatory drug is present on said outward facing surface.
Claim 14
Dependent Claim
28 words
The stent of claim 12, wherein said drugs are incorporated in a biodegradable material for timed release thereof from the rough outer surface when said stent is implanted.
Claim 15
Dependent Claim
21 words
The stent of claim 1, wherein said ceramic-like material is selected from a group consisting of iridium oxide or titanium nitrate.
Claim 16
Dependent Claim
14 words
The stent of claim 1, wherein said base layer is medical grade stainless steel.
Claim 17
Dependent Claim
59 words
A metallic device acceptable for implantation in a human body, comprising a biocompatible metal base; a thin, continuous, tightly adherent first layer of noble metal or alloy thereof overlying an exposed surface area of said metal base; and a biocompatible metal outer layer having a relatively rough porous surface with interstices therein adherent to and overlying said first layer.
Claim 18
Dependent Claim
59 words
A metallic device acceptable for implantation in a human body, comprising a biocompatible metal base; a thin, continuous, tightly adherent first layer of noble metal or alloy thereof overlying an exposed surface area of said metal base; and a biocompatible metal outer layer having a relatively rough porous surface with interstices therein adherent to and overlying said first layer.
Claim 19
Dependent Claim
30 words
The device of claim 16, wherein said base is hollow and the composite thickness of said base, said first layer and said outer layer is less than approximately 60 μm.
Claim 20
Dependent Claim
43 words
The device of claim 16, wherein the interstices in said rough porous surface of said outer layer are at least partially filled with a substance selected to enhance the compatibility of the device in the body in which it is to be implanted.
Claim 21
Dependent Claim
33 words
The device of claim 18, wherein said substance is contained within a carrier which is biodegradable in the presence of body fluid, for release of said substance from the carrier during disintegration thereof.
Claim 22
Dependent Claim
22 words
The device of claim 16, wherein said first layer and said outer layer are selected to avoid a substantial galvanic potential therebetween.
Claim 23
Dependent Claim
40 words
The device of claim 20, wherein said first layer is at least primarily composed of gold and said outer layer is selected from a group consisting of an oxide, hydroxide or nitrate of a metal compatible with said first layer.
Claim 24
Dependent Claim
13 words
The device of claim 21, wherein said compatible metal is a noble metal.
Claim 25
Dependent Claim
41 words
The device of claim 21, wherein said first layer has a thickness in a range from approximately 3 μm to approximately 6 μm, and said outer layer has a thickness in a range from approximately 500 nm to approximately 1.5 μm.
Claim 26
Dependent Claim
40 words
The device of claim 17, wherein said first layer is at least primarily composed of gold and said outer layer is selected from a group consisting of an oxide, hydroxide or nitrate of a metal compatible with said first layer.
Claim 27
Dependent Claim
13 words
The device of claim 24, wherein said compatible metal is a noble metal.
Claim 28
Dependent Claim
48 words
The device of claim 24, wherein said first layer has a thickness in a range from about 3 μm to about 6 μm covering both sides of the hollow base, and said outer layer has a thickness in a range from about 500 nm to about 1.5 μm.
Claim 29
Dependent Claim
70 words
The device of claim 26, wherein said device is a stent for implantation in a blood vessel of the body or in an endoluminal duct or tract of the body for maintaining an open lumen at the implant site of the stent, and said hollow base has a thickness sufficient to resist recoil of the vessel, duct or tract after expansion of the stent to its fully deployed diameter therein.
Claim 30
Dependent Claim
24 words
The device of claim 27, wherein said base is composed of stainless steel having a thickness equal to or less than about 50 μm.
Claim 31
Dependent Claim
66 words
The device of claim 27, wherein the interstices in said rough porous surface of said outer layer at both sides of said base of the stent are at least partially filled with drugs selected to inhibit closure of the central lumen of said stent and to inhibit inflammation and proliferation of tissue in the vessel, duct or tract at the implant site of the stent therein.
Claim 32
Dependent Claim
36 words
The device of claim 29, wherein said at least partial fill of drugs is of adequate amount to reduce friction for facilitating advancement of the stent through the vessel, duct or tract to said implant site.
Claim 33
Dependent Claim
33 words
The device of claim 29, wherein said drugs are contained within a carrier which is biodegradable in the presence of body fluid, for release of said drugs from the carrier during disintegration thereof.
Claim 34
Dependent Claim
62 words
The device of claim 27, wherein said rough porous surface of said outer layer at both sides of said base of the stent has a vector present thereon selected for transfer of genetic information to target cells in tissue at the inner lining of said vessel, duct or tract to inhibit proliferation of tissue growth at the implant site of the stent.
Claim 35
Dependent Claim
19 words
The device of claim 32, wherein said vector is incorporated in a biodegradable carrier on said rough porous surface.
Claim 36
Dependent Claim
12 words
The device of claim 32, wherein said vector is a viral vector.
Claim 37
Dependent Claim
12 words
The device of claim 32, wherein said vector is a non-viral vector.
Claim 38
Dependent Claim
43 words
The device of claim 23, wherein said rough porous surface of said outer layer at both sides of said base has a vector present thereon selected for transfer of genetic information to target cells in tissue at the implant site of the device.
Claim 39
Dependent Claim
19 words
The device of claim 36, wherein said vector is incorporated in a biodegradable carrier on said rough porous surface.
Claim 40
Independent Claim
76 words
A device adapted to be implanted in a human body, comprising a substantially continuous inner layer of noble metal or alloy; and a biocompatible outer layer of an oxide, hydroxide or nitrate of metal having a comparatively rough porous surface and a galvanic potential relative to said inner layer which is insufficient to cause deterioration of metal in contact with said inner layer; said outer layer overlying and in intimate bonded relation to said inner layer.
Claim 41
Independent Claim
76 words
A device adapted to be implanted in a human body, comprising a substantially continuous inner layer of noble metal or alloy; and a biocompatible outer layer of an oxide, hydroxide or nitrate of metal having a comparatively rough porous surface and a galvanic potential relative to said inner layer which is insufficient to cause deterioration of metal in contact with said inner layer; said outer layer overlying and in intimate bonded relation to said inner layer.
Claim 42
Dependent Claim
14 words
The device of claim 38, wherein said outer layer is composed of iridium oxide.
Claim 43
Dependent Claim
22 words
The device of claim 39, including a stainless steel base underlying and adhered to said inner layer remote from said outer layer.
Claim 44
Dependent Claim
50 words
The device of claim 40, wherein said device is a stent, said base is a tube having a sidewall laced with struts separated by holes through the sidewall, said struts having a composite thickness less than about 60 μm which includes the thicknesses of said overlying inner and outer layers.
References Cited (Backward Citations)
US4101984A
Cited
US5163958A
Cited
US5591224A
Cited
US5824077A
Cited
US5607463A
Cited
US5607442A
Cited
US5858556A
Cited
US5843172A
Cited
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 |