US5356433A
Expired / Lapsed
US
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Biocompatible metal surfaces
Assignee: Cordis Corp
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Filing: 1993-11-03
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Granted: 1994-10-18
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Expires: 2013-11-03
Abstract
Abstract Metallic surfaces of medical devices or components of medical devices are provided that have enhanced biocompatibility properties. The surfaces are prepared by a two-step procedure including covalently linking an organosilane having amine reactive sites with the surface of the metallic member, typically through a metal oxide thereof. Thereafter, a biologically active agent is covalently linked to the organosilane coating. The two-step process is particularly advantageous for preparing medical devices in the form of stents which need to be bent and flexed during implantation procedures.
Inventors
- 👤 Stephen M. Rowland
- 👤 Kimberly D. Stanley
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 22:53
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/82; A61F2/86; A61F2/88; A61L; A61L31/00; A61L31/08; A61L31/10; A61L31/14; A61L31/16; A61L33/00; A61L33/0005; A61L33/0011; A61L33/0023; A61F2250/00; A61F2250/0058; A61F2250/0067; A61L2300/00; A61L2300/40; A61L2300/42; A61L2300/60; A61L2300/606; Y; Y10; Y10S; Y10S623/00; Y10S623/90; Y10S623/901
Claims Analysis
Total Claims: 12
Claim 1
Independent Claim
175 words
A medical device having a biocompatible surface, the biocompatible surface having been made by a process comprising the steps of: providing a metallic member having a tantalum oxide-containing surface thereof, said metallic member being flexible and being sized and shaped as a stent; treating the tantalum oxide containing surface with an amino-terminated organosilane having amine reactive sites and covalently linking the organosilane with the flexible metallic member to effect a condensation reaction that covalently links the tantalum oxide and silicon moieties of the organosilane in order to form a flexible organosilane-coated tantalum stent; applying a biologically active agent compostion to the organosilane-coated tantalum stent and forming a covalent linkage between the organosilane and the biologically active agent to provide a coated flexible tantalum stent; and the coated flexible tantalum stent thus formed has a coating which withstands cracking upon flexure, and the tantalum stent thus formed is a biocompatible tantalum stent which, when implanted within a living body, prevents substantial thrombus from occurring on its surface while not significantly interfering with endothelialization of said surface.
Claim 2
Dependent Claim
175 words
A medical device having a biocompatible surface, the biocompatible surface having been made by a process comprising the steps of: providing a metallic member having a tantalum oxide-containing surface thereof, said metallic member being flexible and being sized and shaped as a stent; treating the tantalum oxide containing surface with an amino-terminated organosilane having amine reactive sites and covalently linking the organosilane with the flexible metallic member to effect a condensation reaction that covalently links the tantalum oxide and silicon moieties of the organosilane in order to form a flexible organosilane-coated tantalum stent; applying a biologically active agent compostion to the organosilane-coated tantalum stent and forming a covalent linkage between the organosilane and the biologically active agent to provide a coated flexible tantalum stent; and the coated flexible tantalum stent thus formed has a coating which withstands cracking upon flexure, and the tantalum stent thus formed is a biocompatible tantalum stent which, when implanted within a living body, prevents substantial thrombus from occurring on its surface while not significantly interfering with endothelialization of said surface.
Claim 3
Dependent Claim
36 words
The medical device in accordance with claim 1, wherein the covalent linkage of the applying and forming step is between the amine moiety of the amino-terminated organosilane and a carboxyl moiety of the biologically active agent.
Claim 4
Dependent Claim
56 words
The medical device in accordance with claim 1, wherein said step of treating and covalently linking includes dipping the metallic member into an organosilane of the formula NH 2 --R--Si--(OR') n , wherein R is a short chain length aliphatic group, R' is selected from the group consisting of methyl and ethyl, and n is 3.
Claim 5
Dependent Claim
27 words
The medical device in accordance with claim 1, further including curing the organosilane-coated metallic member at an elevated temperature prior to said step of applying and forming.
Claim 6
Dependent Claim
18 words
The medical device in accordance with claim 1, wherein said flexible metallic member has a generally helical configuration.
Claim 7
Dependent Claim
20 words
The medical device in accordance with claim 1, wherein said flexible metallic member is a generally helically wound tantalum stent.
Claim 8
Dependent Claim
150 words
A medical device having a biocompatible anti-thrombogenic tantalum surface, comprising: a metallic member for a medical device, the metallic member having a tantalum oxide surface and being flexible and being sized and shaped as a stent, the metallic member having a biologically active surface treatment covalently adhered to the tantalum oxide surface; said biologically active surface treatment including an organosilane component having amine reactive sites, the organosilane component having silicon moieties covalently linked to tantalum oxide moieties of the metallic member, said biologically active surface treatment further including a biologically active agent covalently bound to the organosilane component to define a biocompatible tantalum stent; and said biocompatible tantalum stent has a surface which substantially prevents thrombus formation thereonto while avoiding any significant interference of the development of endothelialization of the biocompatible tantalum stent, and said biocompatible tantalum stent has a coating which is flexible and which withstands cracking upon flexure.
Claim 9
Dependent Claim
150 words
A medical device having a biocompatible anti-thrombogenic tantalum surface, comprising: a metallic member for a medical device, the metallic member having a tantalum oxide surface and being flexible and being sized and shaped as a stent, the metallic member having a biologically active surface treatment covalently adhered to the tantalum oxide surface; said biologically active surface treatment including an organosilane component having amine reactive sites, the organosilane component having silicon moieties covalently linked to tantalum oxide moieties of the metallic member, said biologically active surface treatment further including a biologically active agent covalently bound to the organosilane component to define a biocompatible tantalum stent; and said biocompatible tantalum stent has a surface which substantially prevents thrombus formation thereonto while avoiding any significant interference of the development of endothelialization of the biocompatible tantalum stent, and said biocompatible tantalum stent has a coating which is flexible and which withstands cracking upon flexure.
Claim 10
Dependent Claim
18 words
The medical device in accordance with claim 7, wherein said flexible metallic member has a generally helical configuration.
Claim 11
Dependent Claim
19 words
The medical device in accordance with claim 7, wherein the metallic member is a generally helically wound tantalum stent.
Claim 12
Dependent Claim
60 words
The medical device in accordance with claim 9, wherein said organosilane component is of the formula NH 2 --R--Si(OR') 3 , wherein R is a short chain length aliphatic group and R' is selected from the group consisting of methyl and ethyl, and said biologically active agent is selected from the group consisting of a mucopolysaccharide and a glucose amine.
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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) | 1997-10-17 | 1998-04-18 | 1998-10-18 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2001-10-17 | 2002-04-18 | 2002-10-18 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2005-10-17 | 2006-04-18 | 2006-10-18 | $7700.00 | Window Closed / Lapsed |