Metallic structures incorporating bioactive materials and methods for creating the same

• US 20060062820A1
• Filed: 08/12/2005
• Published: 03/23/2006
• Est. Priority Date: 09/19/2001
• Status: Active Grant

• Current Assignee: Celonova Biosciences, Inc. (Boston Scientific Corporation)
• Original Assignee: Medlogics Device Corporation
• Inventors: Gertner, Michael E., Klein, Richard L., Maier, Nathan Christopher, Dadvand, Nazila
• Granted Patent: US 7,776,379 B2
• Time in Patent Office: Days
• US Class Current: 424/422
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/434 of enzymes
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 27/30 Inorganic materials
• CPC Class Codes: A61L 27/42 having an inorganic matrix
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/082 Inorganic materials
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 31/121 having an inorganic matrix
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: B82Y 30/00 Nanotechnology for materials or surface science, e.g. nanocomposites
• CPC Class Codes: C23C 18/1605 by masking
• CPC Class Codes: C23C 18/1651 Two or more layers only obtained by electroless plating
• CPC Class Codes: C23C 18/1653 Two or more layers with at least one layer obtained by electroless plating and one layer obtained by electroplating
• CPC Class Codes: C23C 18/1662 Use of incorporated material in the solution or dispersion, e.g. particles, whiskers, wires
• CPC Class Codes: C23C 18/1689 After-treatment
• CPC Class Codes: C23C 18/1831 Use of metal, e.g. activation, sensitisation with noble metals
• CPC Class Codes: C25D 15/00 : Electrolytic or electrophoretic production of coatings containing embedded materials, e.g. particles, whiskers, wires
• CPC Class Codes: C25D 5/022 : using masking means
• CPC Class Codes: C25D 5/48 : After-treatment of electroplated surfaces
• CPC Class Codes: C25D 5/617 : Crystalline layers
• CPC Class Codes: C25D 5/619 : Amorphous layers
• CPC Class Codes: C25D 5/623 : Porosity of the layers

Abstract

Disclosed herein are methods to create medical devices and medical devices including bioactive composite structures. The methods include using template-assisted electro- or electroless deposition or codeposition methods for providing implantable medical devices coated with bioactive composite structures and also include layering deposited or codeposited metal layers with layers of bioactive materials. In one use, the implantable medical devices of the present invention include stents with bioactive composite structure coatings.

Claims

1. A method comprising:

creating a template on the surface of a substrate;

providing a solution comprising metal ions;

contacting said substrate with said solution;

forming a composite structure on portions of said substrate not covered by said template using an electrochemical process;

removing said template from said substrate after said formation of said composite structure thus leaving pores in said structure; and

loading at least one bioactive material into said pores thus forming a bioactive composite structure over said substrate.

2. The method according to claim 1, wherein said electrochemical process is an electrodeposition process or an electroless deposition process.

3. The method according to claim 2, wherein said method further comprises providing at least one bioactive material in said solution and said electrodeposition or electroless deposition process is an electrocodeposition or electroless codeposition process and said formed composite structure after said contacting is a bioactive composite structure.

4. The method according to claim 3, wherein said bioactive material is selected from the group consisting of rapamycin, paclitaxel and 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors.

5. The method according to claim 1, wherein said substrate is a stent.

6. A medical device comprising a bioactive composite structure wherein said bioactive composite structure is formed by:

creating a template on the surface of a substrate;

providing a solution comprising metal ions;

contacting said substrate and said solution;

forming a composite structure on portions of said substrate not covered by said template using an electrochemical process;

removing said template from said substrate after said formation of said composite structure thus leaving pores in said structure; and

loading at least one bioactive material into said pores thus forming a bioactive composite structure over said substrate.

7. The medical device according to claim 6, wherein said electrochemical process is a electrodeposition process or electroless deposition process.

8. The medical device according to claim 7, wherein said providing step further comprises providing at least one bioactive material in said solution, and said electrodeposition or electroless deposition process is an electrocodeposition or electroless codeposition process and said formed composite structure after said contacting is a bioactive composite structure.

9. The medical device according to claim 6, wherein said substrate is a stent.

10. A stent comprising a bioactive composite structure wherein said bioactive composite structure comprises pores, metal material around said pores and at least one bioactive material within said pores and said metal material.

11. A method comprising:

providing a first solution comprising metal ions;

contacting a substrate with said first solution;

forming a first metal layer on said substrate using an electrochemical process;

applying at least one bioactive material to said first metal layer;

contacting said substrate with said first solution or a second solution;

forming a second layer metal layer on said substrate using an electrochemical process.

12. The method according to claim 11, wherein said electrochemical process is an electrodeposition process or an electroless deposition process.

13. The method according to claim 11, wherein said first solution, said second solution or said first and said second solution further comprise at least one bioactive material and said first metal layer, said second metal layer or said first and second metal layer further comprise codeposited at least one bioactive material.

14. The method according to claim 11, wherein said bioactive material is selected from the group consisting of rapamycin, paclitaxel and HMG-CoA reductase inhibitors.

15. The method according to claim 11, wherein said substrate is a stent.

16. A medical device comprising a bioactive composite structure wherein said bioactive composite structure is formed by:

providing a first solution comprising metal ions;

contacting a substrate with said first solution;

forming a first metal layer on said substrate using an electrochemical process;

applying at least one bioactive material to said first metal layer;

contacting said substrate with said first solution or a second solution;

forming a second layer metal layer on said substrate using an electrochemical process.

17. The medical device according to claim 16, wherein said electrochemical process is an electrodeposition process or an electroless codeposition process.

18. The medical device according to claim 16, wherein said first solution, said second solution or said first and said second solution further comprise at least one bioactive material and said first metal layer, said second metal layer or said first and second metal layer further comprise codeposited at least one bioactive material.

19. The medical device according to claim 16, wherein said substrate is a stent.

20. A stent comprising a bioactive composite structure wherein said bioactive composite structure comprises alternating layers of metal and bioactive materials and wherein said alternating layers are formed by:

providing a first solution comprising metal ions;

contacting a substrate with said first solution;

forming a first metal layer on said substrate using an electrochemical process;

drying said substrate after said contacting with said solution;

applying at least one bioactive material to said first metal layer;

drying said substrate after said applying;

contacting said substrate with a second solution;

forming a second layer metal layer on said substrate using an electrochemical process.