Method of Forming a Drug-Eluting Medical Device

• US 8,333,801 B2
• Filed: 09/17/2010
• Issued: 12/18/2012
• Est. Priority Date: 09/17/2010
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Bienvenu, Ryan
• Primary Examiner(s): Banks, Derris
• Assistant Examiner(s): Green, Anthony
• Application Number:
  US12/884,343
• Publication Number:
  US 20120067008A1
• Time in Patent Office: 823 Days
• Field of Search: 294/58, 295/57, 623/1.15, 623/1.22, 623/1.23, 623/1.27, 623/1.39, 623/1.42, 216/56, 216/75, 216/83, 216/96, 216/100
• US Class Current: 623/1.42
• 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 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• 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: A61L 2300/406 Antibiotics
• 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 31/121 having an inorganic matrix
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: Y10T 29/49885 with coating before or during assembling
• CPC Class Codes: Y10T 29/49995 Shaping one-piece blank by removing material

Abstract

A method of forming a stent includes the steps of forming an elongated composite member or plurality of elongated composite members into a stent pattern having struts interconnected by crowns, the composite member including an outer member and a core member. Openings are formed through the outer member of the composite member. The composite member is processed to remove the core member from at least a plurality of the struts of the stent without adversely affecting the outer member and such that the core member is not removed from at least a plurality of the crowns of the stent, thereby leaving the outer member with a lumen in at least a plurality of the struts and the outer member with the core member in at least a plurality of the crowns. The lumens may then be filled with a biologically or pharmacologically active substance.

Claims

1. A method of forming a stent comprising the steps of:

utilizing an elongated composite member including an outer member and a core member disposed within a lumen of the outer member;

shaping the composite member into a stent pattern including a waveform having a plurality of struts interconnected by crowns;

forming openings through the outer member;

after the step of shaping the composite member into the pattern, processing the composite member such that the core member is removed from at least a plurality of the struts of the waveform without adversely affecting the outer member and such that the core member is not removed from at least a plurality of the crowns of waveform, thereby leaving the outer member with a lumen in at least a plurality of the struts and the outer member with the core member in at least a plurality of the crowns.

2. The method of claim 1, further comprising the step of filling the lumens with a biologically or pharmacologically active substance after the core member has been removed.

3. The method of claim 2, wherein the biologically or pharmacologically active substance is selected from the group consisting of antineoplastic, antimitotic, antiinflammatory, antiplatelet, anticoagulant, anti fibrin, antithrombin, antiproliferative, antibiotic, antioxidant, and antiallergic substances as well as combinations thereof.

4. The method of claim 1, wherein the step of processing the composite member comprises exposing the composite member to an etchant that reacts with the core member to remove the core member, wherein the etchant does not react with the outer member.

5. The method of claim 4, wherein the etchant is a liquid chemical that dissolves the core member.

6. The method of claim 5, wherein the etchant is a gas.

7. The method of claim 6, wherein the outer member is formed from MP35N, the core member is formed from one of tantalum, tungsten, molybdenum, niobium, rhenium, carbon, germanium, and silicon, and the etchant is xenon difluoride.

8. The method of claim 4, wherein the core member is soluble in the etchant and the outer member is not soluble in the etchant.

9. The method of claim 1, wherein the core member is removed from all of the struts.

10. The method of claim 1, wherein the core member is not removed from any of the crowns.

11. The method of claim 1, wherein the core member is more radiopaque than the outer member.

12. The method of claim 1, further comprising the step of removing a portion of the core member in the at least a plurality of crowns with the core member remaining such that a lumen is provided through the crowns while a portion of the core member remains in the crowns.

13. A method of forming a stent comprising the steps of:

utilizing a plurality of elongated composite members, each composite member including an outer member and an inner member disposed within a lumen of the outer member;

shaping each composite member into a waveform having a plurality of struts interconnected by crowns;

wrapping each waveform into a cylindrical element;

aligning the cylindrical elements along a common longitudinal axis and joining the cylindrical elements together to form a tubular stent;

forming openings through the outer members;

after the step of shaping the composite members into a waveform, processing the composite members such that the inner member is removed from at least a plurality of the struts of the waveform without adversely affecting the outer member and such that the core member is not removed from at least a plurality of the crowns of the waveform, thereby leaving the outer member with a lumen in at least a plurality of the struts and the outer member with a core member in at least a plurality of the crowns.

14. The method of claim 13, further comprising the step of filling the lumens with a biologically or pharmacologically active substance after the core member has been removed.

15. The method of claim 14, wherein the biologically or pharmacologically active substance is selected from the group consisting of antineoplastic, antimitotic, antiinflammatory, antiplatelet, anticoagulant, anti fibrin, antithrombin, antiproliferative, antibiotic, antioxidant, and antiallergic substances as well as combinations thereof.

16. The method of claim 13, wherein the step of processing the composite member comprises exposing the composite member to an etchant that reacts with the core member to remove the core member, wherein the etchant does not react with the outer member.

17. The method of claim 16, wherein the etchant is a liquid chemical that dissolves the core member.

18. The method of claim 17, wherein the etchant is a gas.

19. The method of claim 18, wherein the outer member is formed from MP35N, the core member is formed from one of tantalum, tungsten, molybdenum, niobium, rhenium, carbon, germanium, and silicon, and the etchant is xenon difluoride.

20. The method of claim 16, wherein the core member is soluble in the etchant and the outer member is not soluble in the etchant.

21. The method of claim 13, wherein the core member is removed from all of the struts.

22. The method of claim 13, wherein the core member is not removed from any of the crowns.

23. The method of claim 13, wherein the core member is more radiopaque than the outer member.

24. The method of claim 13, further comprising the step of removing a portion of the core member in the at least a plurality of crowns with the core member remaining such that a lumen is provided through the crowns while a portion of the core member remains in the crowns.