CA2500711A1 - Medical devices and methods of making the same - Google Patents

Medical devices and methods of making the same Download PDF

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Publication number
CA2500711A1
CA2500711A1 CA 2500711 CA2500711A CA2500711A1 CA 2500711 A1 CA2500711 A1 CA 2500711A1 CA 2500711 CA2500711 CA 2500711 CA 2500711 A CA2500711 A CA 2500711A CA 2500711 A1 CA2500711 A1 CA 2500711A1
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CA
Canada
Prior art keywords
stent
layer
radiopaque material
radiopaque
outer layer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA 2500711
Other languages
French (fr)
Other versions
CA2500711C (en
Inventor
Verivada Chandrasekaran
Karl Morris Schmidt
Christopher Torres Molina
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Boston Scientific Ltd Barbados
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Individual
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Publication of CA2500711A1 publication Critical patent/CA2500711A1/en
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Publication of CA2500711C publication Critical patent/CA2500711C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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    • CCHEMISTRY; METALLURGY
    • C23COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
    • C23CCOATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
    • C23C8/00Solid state diffusion of only non-metal elements into metallic material surfaces; Chemical surface treatment of metallic material by reaction of the surface with a reactive gas, leaving reaction products of surface material in the coating, e.g. conversion coatings, passivation of metals
    • C23C8/06Solid state diffusion of only non-metal elements into metallic material surfaces; Chemical surface treatment of metallic material by reaction of the surface with a reactive gas, leaving reaction products of surface material in the coating, e.g. conversion coatings, passivation of metals using gases
    • C23C8/08Solid state diffusion of only non-metal elements into metallic material surfaces; Chemical surface treatment of metallic material by reaction of the surface with a reactive gas, leaving reaction products of surface material in the coating, e.g. conversion coatings, passivation of metals using gases only one element being applied
    • C23C8/10Oxidising
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08Materials for coatings
    • A61L31/082Inorganic materials
    • A61L31/088Other specific inorganic materials not covered by A61L31/084 or A61L31/086
    • AHUMAN NECESSITIES
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    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/18Materials at least partially X-ray or laser opaque
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    • C23C14/00Coating by vacuum evaporation, by sputtering or by ion implantation of the coating forming material
    • C23C14/06Coating by vacuum evaporation, by sputtering or by ion implantation of the coating forming material characterised by the coating material
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    • C23C14/16Metallic material, boron or silicon on metallic substrates or on substrates of boron or silicon
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    • C23C14/00Coating by vacuum evaporation, by sputtering or by ion implantation of the coating forming material
    • C23C14/22Coating by vacuum evaporation, by sputtering or by ion implantation of the coating forming material characterised by the process of coating
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    • C23C28/00Coating for obtaining at least two superposed coatings either by methods not provided for in a single one of groups C23C2/00 - C23C26/00 or by combinations of methods provided for in subclasses C23C and C25C or C25D
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    • C23C28/00Coating for obtaining at least two superposed coatings either by methods not provided for in a single one of groups C23C2/00 - C23C26/00 or by combinations of methods provided for in subclasses C23C and C25C or C25D
    • C23C28/02Coating for obtaining at least two superposed coatings either by methods not provided for in a single one of groups C23C2/00 - C23C26/00 or by combinations of methods provided for in subclasses C23C and C25C or C25D only coatings only including layers of metallic material
    • C23C28/021Coating for obtaining at least two superposed coatings either by methods not provided for in a single one of groups C23C2/00 - C23C26/00 or by combinations of methods provided for in subclasses C23C and C25C or C25D only coatings only including layers of metallic material including at least one metal alloy layer
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    • C23CCOATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
    • C23C28/00Coating for obtaining at least two superposed coatings either by methods not provided for in a single one of groups C23C2/00 - C23C26/00 or by combinations of methods provided for in subclasses C23C and C25C or C25D
    • C23C28/02Coating for obtaining at least two superposed coatings either by methods not provided for in a single one of groups C23C2/00 - C23C26/00 or by combinations of methods provided for in subclasses C23C and C25C or C25D only coatings only including layers of metallic material
    • C23C28/023Coating for obtaining at least two superposed coatings either by methods not provided for in a single one of groups C23C2/00 - C23C26/00 or by combinations of methods provided for in subclasses C23C and C25C or C25D only coatings only including layers of metallic material only coatings of metal elements only
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    • C23C28/00Coating for obtaining at least two superposed coatings either by methods not provided for in a single one of groups C23C2/00 - C23C26/00 or by combinations of methods provided for in subclasses C23C and C25C or C25D
    • C23C28/02Coating for obtaining at least two superposed coatings either by methods not provided for in a single one of groups C23C2/00 - C23C26/00 or by combinations of methods provided for in subclasses C23C and C25C or C25D only coatings only including layers of metallic material
    • C23C28/028Including graded layers in composition or in physical properties, e.g. density, porosity, grain size
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    • C23C28/00Coating for obtaining at least two superposed coatings either by methods not provided for in a single one of groups C23C2/00 - C23C26/00 or by combinations of methods provided for in subclasses C23C and C25C or C25D
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Abstract

An endoprosthesis, such as a stent, having a layer that can enhance the biocompatibility of the endoprosthesis, and methods of making the endoprosthesis are disclosed.

Claims (42)

1. ~A stent, comprising:
a member including a first portion; and a second portion disposed outwardly of the first portion, the second portion being more radiopaque than the first portion and having a first layer including a radiopaque material, and a second layer defining an outer surface of the member and including the radiopaque material and a second material.
2. ~The stent of claim 1, wherein the second layer comprises an alloy of the radiopaque material and the second material.
3. ~The stent of claim 1, wherein the radiopaque material is capable of attenuating an incident X-ray beam by more than about 70%.
4. ~The stent of claim 1, wherein the radiopaque material is selected from the group consisting of gold, platinum, palladium, and tantalum.
5. ~The stent of claim 1, wherein the second material is selected from the group consisting of titanium, chromium, palladium, niobium, and silicon.
6. ~The stent of claim 1, wherein the first portion comprises a material selected from the group consisting of stainless steel and nickel-titanium alloy
7. ~The stent of claim 1, wherein the first portion is the innermost portion of the member.
8. ~The stent of claim 1, wherein the first portion contacts the second portion.
9. ~The stent of claim 1, further comprising a third portion between the first portion and the second portion.
10. ~The stent of claim 1, further comprising a polymeric layer on the member.
11. ~The stent of claim 1, further comprising a drug-releasing layer on the member.
12. ~A stent, comprising:
a member including a first portion having a first layer including a radiopaque material, and a second layer defining an outer surface of the member and including the radiopaque material and a second material.
13. ~A stent, comprising:
a member having a first portion; and a second portion disposed outwardly of the first portion, the second portion being more radiopaque than the first layer and including a first layer comprising a radiopaque material, and a second layer comprising the radiopaque material and defining an outer surface of the member, the second layer having a lower oxidation potential than an oxidation potential of the first layer.~
14. ~The stent of claim 13, wherein the radiopaque material is capable of attenuating an incident X-ray beam by more than about 70%.
15. ~The stent of claim 13, wherein the radiopaque material is selected from the group consisting of gold, platinum, palladium, and tantalum.
16. The stent of claim 13, wherein the second layer comprises an alloy of the radiopaque material and a second material.
17. The stent of claim 13, wherein the second material is selected from the group consisting of titanium, niobium, palladium, chromium, and silicon.
18. The stent of claim 13, wherein the first portion comprises a material selected from the group consisting of stainless steel and a nickel-titanium alloy.
19. The stent of claim 13, wherein the first portion is the innermost portion of the member.
20. The stent of claim 13, wherein the first portion contacts the second portion.
21. The stent of claim 13, wherein the first and second portions have different compositions.
22. The stent of claim 13, further comprising a polymeric layer on the member.
23. The stent of claim 13, further comprising a drug-releasing layer on the member.
24. A stent, comprising:
a member having a first portion including a first layer comprising a radiopaque material, and a second layer comprising the radiopaque material and defining an outer surface of the member, the second layer having a lower oxidation potential than an oxidation potential of the first layer.
25. ~A stent, comprising:
a member including a first portion having a concentration gradient of a radiopaque material, the first portion defining an outer surface of the member.
26. ~The stent of claim 25, wherein the concentration of the radiopaque material increases as a function of distance from the outer surface.
27. ~The stem of claim 25, wherein the concentration gradient varies substantially linearly along a thickness of the first portion.
28. ~The stent of claim 25, wherein the radiopaque material is capable of attenuating an incident X-ray beam by more than about 70%.
29. ~The stent of claim 25, wherein the radiopaque material is selected from a group consisting of gold, platinum, palladium, and tantalum.
30. ~The stent of claim 25, wherein the first portion is formed of an alloy comprising the radiopaque material and a second material.
31. ~The stent of claim 25, wherein the member further includes a second portion disposed inwardly of the first portion, the second portion being more radiolucent than the first portion.
32. ~A method of making a stent including a member, the method comprising:
forming an outer layer on the member, the outer layer comprising a radiopaque material and a second material; and oxidizing a portion of the outer layer.
33. ~The method of claim 32, wherein oxidizing the portion comprises forming an oxide from the outer layer.
34. The method of claim 32, wherein oxidizing the portion comprises forming a nitride from the outer layer.
35. The method of claim 32, further comprising forming a radiopaque layer comprising the radiopaque material.
36. The method of claim 32, wherein the outer layer is formed with a compositional gradient.
37. The method of claim 32, wherein the outer layer is formed by a process selected from the group consisting of physical vapor deposition, chemical vapor deposition, and electrodeposition.
38. The method of claim 32, wherein oxidizing the portion of the outer layer is performed by electropolishing.
39. The method of claim 32, wherein oxidizing the portion of the outer layer is performed by heating the outer layer in an oxidizing environment.
40. The method of claim 32, wherein oxidizing the portion of the outer layer is performed by ion implanting oxygen in the outer layer and heating the outer layer.
41. The method of claim 32, further comprising forming a polymeric layer on the outer layer.
42. The method of claim 32, further comprising foaming a drug-releasing layer on the outer layer.
CA 2500711 2002-10-02 2003-09-29 Medical devices and methods of making the same Expired - Fee Related CA2500711C (en)

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US10/263,212 2002-10-02
US10/263,212 US6638301B1 (en) 2002-10-02 2002-10-02 Medical device with radiopacity
PCT/US2003/030682 WO2004030578A2 (en) 2002-10-02 2003-09-29 Multilayer stent

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EP (2) EP1549250B1 (en)
JP (1) JP2006501032A (en)
AT (1) ATE392197T1 (en)
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