Flat process of preparing drug eluting stents

• US 8,828,077 B2
• Filed: 05/06/2011
• Issued: 09/09/2014
• Est. Priority Date: 03/15/2006
• Status: Expired due to Fees

• Current Assignee: Medinol Limited (Medinol USA Incorporated)
• Original Assignee: Medinol Limited (Medinol USA Incorporated)
• Inventors: Richter, Jacob
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US13/068,266
• Publication Number:
  US 20110238152A1
• Time in Patent Office: 1,222 Days
• Field of Search: 623/1.15, 623 142- 146
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: C25F 3/00 Electrolytic etching or polishing

Abstract

The present invention provides a method of fabricating a drug delivery stent. In one embodiment, the method involves forming a stent pattern in a flat sheet, where the stent pattern includes reservoirs, generating a flat map of the reservoirs, filling the reservoirs with a composition based on the flat map, and then forming the filled stent pattern into a tubular shape and joining the sides. In another embodiment, the method involves forming a stent pattern in a flat sheet, generating a flat map of discrete portions of the stent pattern that are desirable locations for coating, coating the discrete portions with a composition based on the flat map, and then forming the coated stent pattern into a tubular shape and joining the sides. The invention provides advantages over current methods and drug-delivery stents in that it is faster, more accurate and more cost-efficient manufacturing process for fabricating drug delivery stents, that improves quality and consistency of drug delivery within and across batches of stents, and that permits automated a process of quality control. This method also allows for differential coating on the two surfaces of the stent struts, whereby the two sides are coated with different drugs and/or polymer combinations, or only one side of the strut is coated.

Claims

1. A method of fabricating a filled stent comprising the steps of:

cutting a plurality of stent patterns into a flat sheet of metal, each of said stent patterns comprising stent members and reservoirs, and first and second long sides, each of said reservoirs located on at least one of a first and second major surface and exposed exclusively thereto;

filling said reservoirs of said flat stent pattern with a composition;

folding said filled stent pattern into a tubular shape so that said first and second long sides meet; and

attaching said first and second long sides to form a filled stent;

wherein said filled stent reservoirs and at least one of the first and second major surface are exposed to at least one of a vessel lumen or a vessel wall when the stent is implanted in a vessel.

2. The method of claim 1, wherein said filling step includes filling reservoirs of multiple stent patterns simultaneously.

3. The method of claim 1, wherein said attaching step comprises welding.

4. The method of claim 1, further comprising, prior to said cutting step, the step of preparing a flat stent pattern tool, wherein said cutting step includes employing said tool to generate said stent patterns.

5. The method of claim 1 or 4, further comprising, prior to said filling step, the step of generating a flat map containing information regarding the location of said reservoirs based on one of the group consisting of:

said cut flat stent pattern and a tool used for cutting said flat stent pattern;

wherein said filling step includes using said flat map to fill said reservoirs.

6. The method of claim 5, wherein said generating a flat map step is performed before said cutting step.

7. The method of claim 5, wherein said generating a flat map step is performed after said cutting step.

8. The method of claim 1, wherein said stent members are struts.

9. The method of claim 1, wherein said first long side includes first engagement points and said second long side includes second engagement points and said attaching step includes attaching said first and second long sides at said first and second engagement points, wherein said engagement points are located on said struts.

10. The method of claim 1, wherein said first long side is provided with a plurality of pairs of engagement points, said second long side is provided with a plurality of pairs of engagement points, said plurality of pairs of engagement points disposed substantially opposite each other, said engagement points sized and disposed to communicate when said stent pattern is deformed and rolled into a tubular shape, each pair of said first long side engagement points provided with a bridge disposed between each first long side engagement point comprising said pair, said bridge having a width that is less than the width of other portions of said stent pattern;

wherein said folding step includes disposing a mandrel having a substantially cylindrical external surface and a longitudinal axis between said first long side and said second long side of said sheet, said longitudinal axis substantially parallel to said first and second long sides, and deforming said filled stent pattern around said mandrel into a tubular shape so that said first long side pairs of engagement points contact said second long side pairs of engagement points;

wherein said attaching step includes attaching each of the engagement points to the engagement point with which it is in contact;

said method further comprising, after said folding step;

cutting said bridge.

11. The method of claim 1, wherein said deforming includes allowing a portion of said tubular shaped stent pattern to remain attached to said sheet of metal;

said method further comprising, after said attaching step;

disconnecting said filled stent from said sheet.

12. The method of claim 1, further comprising:

electropolishing said flat stent pattern before said filling step.

13. A stent fabricated by the method of claim 1.

14. A method of filling reservoirs of a drug eluting stent comprising:

providing a flat stent pattern, wherein said stent pattern includes a plurality of reservoirs, wherein said reservoirs are located on a major surface;

generating a flat map containing information regarding the location of said plurality of reservoirs on said flat stent pattern, said flat map based on one of the group consisting of;

said cut flat stent pattern and a tool used for cutting said flat stent pattern;

depositing a composition into said reservoirs using said flat map, while said stent pattern is in a flat configuration.

15. The method of claim 14, wherein said providing step includes providing a plurality of stent patterns, each having reservoirs, said depositing step comprising filling reservoirs of multiple stent patterns simultaneously.

16. A method of fabricating a coated stent comprising the steps of:

cutting a plurality of stent patterns into a flat sheet of metal, each of said stent patterns comprising a plurality of discrete portions, a luminal surface, a vessel wall surface, a first long side, and a second long side;

coating said discrete portions on a surface of each stent pattern with a composition to form a coated stent pattern;

folding said coated stent pattern into a tubular shape so that said first and second long sides meet; and

attaching said first and second long sides to form a coated stent,

wherein said coated surface is exposed to at least one of said vessel lumen or said vessel wall when said stent is implanted in a vessel.

17. The method of claim 16, wherein said discrete portions are non-bending portions.

18. The method of claim 17, wherein said non-bending portions are struts.

19. The method of claim 16, wherein said discrete portions are spots.

20. The method of claim 19, wherein said spots are located on stent struts.

21. The method of claim 16, further comprising, prior to said cutting step, the step of preparing a flat stent pattern tool, wherein said cutting step includes employing said tool to generate said stent patterns.

22. The method of claim 16 or 21, further comprising, prior to said coating step, the step of generating a flat map defining said discrete portions;

said coating step including using said flat map to coat said discrete portions.

23. The method of claim 22, wherein said generating a flat map step is performed before said cutting step.

24. The method of claim 22, wherein said generating a flat map step is performed after said cutting step.

25. The method of claim 16, wherein said coating composition includes a therapeutic agent.

26. The method of claim 16, wherein said coating step includes coating said discrete portions of said luminal surface with a coating composition comprising a first therapeutic agent and coating said discrete portions of said vessel wall surface with a coating composition comprising a second therapeutic agent.

27. The method of claim 16, wherein said coating step includes coating said discrete portions of said vessel wall surface but not said luminal surface.

28. The method of claim 16, wherein said coating step includes coating said discrete portions of said luminal surface but not said vessel wall surface.

29. The method of claim 16, wherein said coating step includes coating discrete portions of multiple stent patterns simultaneously.

30. The method of claim 16, wherein said coating substance is applied by ion beam spraying.

31. The method of claim 16, wherein said coating substance is applied by inkjet.

32. The method of claim 16, wherein said attaching step comprises welding.

33. The method of claim 16, wherein said first long side comprises a plurality of first engagement points and said second long side comprises a plurality of corresponding second engagement points, said first engagement points having a protrusion;

wherein said attaching step comprises attaching each of said plurality of first engagement points to a corresponding second engagement point.

34. A stent fabricated by the method of claim 16.