Medical device for delivering biologically active material

• US 20040249445A1
• Filed: 07/14/2004
• Published: 12/09/2004
• Est. Priority Date: 01/31/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Miller, Matthew, Ehr, Timothy G.J., Rosenthal, Arthur L.
• Granted Patent: US 7,326,245 B2
• Time in Patent Office: Days
• US Class Current: 623/1.15
• 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 end and a second 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; and

wherein at least one of the struts or at least one of the projecting elements comprises a biologically active material.

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 the projecting element is integral with or attached to a single strut only at a single point on the projecting element.

4. The stent of claim 1 wherein at least one strut and at least one projecting element comprise the biologically active material.

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

6. The stent of claim 1 wherein the first projecting element end is integral with the strut.

7. 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.

8. The stent of claim 7 wherein the coating further comprises a polymeric material.

9. The stent of claim 1 wherein the biologically active material is a macrolide selected from sirolimus or everolimus.

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

11. The stent of claim 1, wherein at least one projecting element is configured in a shape selected from a straight rod, a bent rod, a rod having an end with a greater width at the second projecting element end, a rod having a hoop at the second projecting element end, or a truncated circle.

12. The stent of claim 1, 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.

13. The stent of claim 1, 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.

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

15. 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.

16. 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.

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

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

19. The stent of claim 18, wherein the second material is more flexible than the first material.

20. A balloon 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 proximate at least one stent end; and

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

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

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

wherein at least one of the projecting elements comprise a biologically active material.

21. The stent of claim 20 wherein the projecting element is configured such that the projecting element does not expand in width when the stent is radially expanded.

22. The stent of claim 20 wherein the projecting element is integral with or attached to a single strut only at a single point on the projecting element.

23. The stent of claim 20 wherein at least one strut comprises the biologically active material.

24. The stent of claim 20 wherein at least one projecting element comprises a coating comprising the biologically active material.

25. The stent of claim 20 wherein all of the struts and the projecting elements comprise a coating comprising the biologically active material.

26. The stent of claim 20 wherein the biologically active material is selected from paclitaxel, a derivative of paclitaxel or an analog of paclitaxel.

27. A system comprising a balloon expandable stent and a balloon catheter having an inflatable balloon for expanding the stent to an expanded position,

wherein the stent comprises two ends and a tubular sidewall between the two ends, wherein the sidewall comprises a plurality of struts;

and a plurality of projecting elements proximate at least one stent end;

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

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

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

wherein at least one of the struts or one of the projecting elements comprise a biologically active material.

28. The stent of claim 27 wherein the projecting element is configured such that the projecting element does not expand in width when the stent is radially expanded.

29. The stent of claim 27 wherein the projecting element is integral with or attached to a single strut only at a single point on the projecting element.

30. The system of claim 27 wherein at least one strut and at least one projecting element comprises the biologically active material.

31. The system of claim 27 wherein the biologically active material is selected from paclitaxel, a derivative of paclitaxel or an analog of paclitaxel.

32. The stent of claim 27 wherein the projecting elements are integral with the struts.