Medical device for delivering biologically active material

• US 7,326,245 B2
• Filed: 07/14/2004
• Issued: 02/05/2008
• Est. Priority Date: 01/31/2002
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Miller, Matthew, Rosenthal, Arthur L, Ehr, Timothy G. J.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/892,005
• Publication Number:
  US 20040249445A1
• Time in Patent Office: 1,301 Days
• Field of Search: 623 111- 148
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0014 having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61F 2250/0035 differing in release or diffusion time
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. 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 2300/606 Coatings
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

This invention relates generally to a stent comprising a plurality of struts and a plurality of projecting elements integral with the struts. At least some of the struts and some of the projecting elements comprise a biologically active material. The struts are configured in a tubular shape or tubular sidewall having two ends. One end of at least one of the projecting elements defines an end of the stent when the stent is expanded. The invention is also directed to a method for delivering the biologically active material to body tissue of a patient by inserting such an expandable stent into body of the patient. The invention is further directed to a system comprising the expandable stent and a balloon catheter for expanding the stent.

Claims

1. An expandable stent comprising two ends and a tubular sidewall between the two ends,

wherein the sidewall comprises a plurality of struts, and a plurality of projecting elements located proximate at least one stent end;

wherein each projecting element comprises a first projecting element end and a second projecting element end;

wherein the first projecting element end is integral with or attached to a strut;

wherein the second projecting element end is capable of defining at least one stent end when the stent is in an expanded position;

wherein at least one of the struts or at least one of the projecting elements comprises a biologically active material, wherein the biologically active material comprises an antiproliferative agent; and

wherein at least one projecting element is configured in a shape of a rod having an end with a greater width at the second projecting element end, and at least one indentation for containing the biologically active material located at the second projecting element end.

2. The stent of claim 1, wherein the projecting element is configured such that the projecting element does not expand in width when the stent is radially expanded.

3. The stent of claim 1, wherein all of the struts and all of the projecting elements comprise the biologically active material.

4. The stent of claim 1, wherein the strut or projecting element that comprises the biologically active material comprises a coating containing the biologically active material.

5. The stent of claim 4, wherein the coating further comprises a polymeric material.

6. The stent of claim 1, wherein the biologically active material is sirolimus or everolimus.

7. The stent of claim 1, wherein the biologically active material is paclitaxel, a derivative of paclitaxel or an analog of paclitaxel.

8. The stent of claim 1, wherein the struts and the projecting elements comprise the same material.

9. The stent of claim 1, wherein the struts comprise a first material and the projecting elements comprise a second material.

10. The stent of claim 1, wherein the struts are configured as a plurality of apexes and valleys, and wherein the projecting elements are integral with or attached to at least one of the valleys.

11. The stent of claim 1, wherein the projecting elements are distributed uniformly at the ends of the stent.

12. The stent of claim 1, wherein the struts are configured as a plurality of apexes and valleys, and wherein the projecting elements are integral with or attached to at least one of the apexes.

13. The stent of claim 9, wherein the second material is more flexible than the first material.

14. The stent of claim 1, wherein the stent is a balloon expandable stent.

15. An expandable stent comprising two ends and a tubular sidewall between the two ends,

wherein the sidewall comprises a plurality of struts, and a plurality of projecting elements located proximate at least one stent end;

wherein each projecting element comprises a first projecting element end and a second projecting element end;

wherein the first projecting element end is integral with or attached to a strut;

wherein the second projecting element end is capable of defining at least one stent end when the stent is in an expanded position;

wherein at least one of the struts or at least one of the projecting elements comprises a biologically active material, wherein the biologically active material comprises an antiproliferative agent; and

wherein at least some of the projecting elements comprise an opening therein and wherein the stent further comprises a ribbon comprising the biologically active material, and wherein the ribbon passes through at least one of the openings in the projecting elements.

16. The stent of claim 15, wherein the projecting element is configured such that the projecting element does not expand in width when the stent is radially expanded.

17. The stent of claim 15, wherein all of the struts and all of the projecting elements comprise the biologically active material.

18. The stent of claim 15, wherein the strut or projecting element that comprises the biologically active material comprises a coating containing the biologically active material.

19. The stent of claim 18, wherein the coating further comprises a polymeric material.

20. The stent of claim 15, wherein the biologically active material is sirolimus or everolimus.

21. The stent of claim 15, wherein the biologically active material is paclitaxel, a derivative of paclitaxel or an analog of paclitaxel.

22. The stent of claim 15, wherein the struts and the projecting elements comprise the same material.

23. The stent of claim 15, wherein the struts comprise a first material and the projecting elements comprise a second material.

24. The stent of claim 23, wherein the second material is more flexible than the first material.

25. The stent of claim 15, wherein the struts are configured as a plurality of apexes and valleys, and wherein the projecting elements are integral with or attached to at least one of the valleys.

26. The stent of claim 15, wherein the projecting elements are distributed uniformly at the ends of the stent.

27. The stent of claim 15, wherein the struts are configured as a plurality of apexes and valleys, and wherein the projecting elements are integral with or attached to at least one of the apexes.

28. The stent of claim 15, wherein the stent is a balloon expandable stent.