Stent with channel(s) for containing and delivering a biologically active material and method for manufacturing the same

• US 6,752,829 B2
• Filed: 01/30/2001
• Issued: 06/22/2004
• Est. Priority Date: 01/30/2001
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Girton, Timothy Samuel, Kocur, Gordon John
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): Hamilton, Lalita M.
• Application Number:
  US09/774,218
• Publication Number:
  US 20020103527A1
• Time in Patent Office: 1,239 Days
• Field of Search: 623/1.1, 623/1.11, 623/1.13, 623/1.16, 623/1.27, 623/1.3, 623/1.35, 623/1.42, 623/1.44, 606/108
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• 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

Abstract

An implantable stent prosthesis comprises a sidewall and at least one channel for containing a biologically active material. A method for making such stent prosthesis is also disclosed. In the method, at least one tube or mandrel is placed in contact with a covering material on a stent and surrounded by the covering material to form a channel. Alternatively, a channel can be formed by covering tube or mandrel with a channel material and exposing the covered tube or mandrel to an appropriate treatment. The channel can be attached to a sidewall of a stent or attached to a strut material to form a stent wire. A method of treating an afflicted area of a body lumen by implanting the stent prosthesis is also disclosed.

Claims

1. An implantable stent prosthesis for delivery of a biologically active material to a body lumen of a patient, wherein the stent comprises:

(a) a sidewall having a portion comprising a plurality of struts defining a plurality of openings, each strut having an exterior surface, and

(b) at least one channel for containing a biologically active material, wherein the channel is attached to the sidewall and the channel comprises a channel space defined by a single continuous channel wall.

2. The stent of claim 1, wherein the stent sidewall has an interior luminal surface and an opposed exterior surface extending along a longitudinal stent axis;

and wherein the stent further comprises a stent covering made of a covering material disposed over at least the interior luminal surface or the exterior surface of the stent sidewall.

3. The stent of claim 2, wherein the covering material is selected from the group consisting of silicones, polyurethanes, thermoplastic elastomers, ethylene vinyl acetate copolymers, polyolefin elastomers, EPDM rubbers, polytetrafluoroethylene and expanded polytetrafluoroethylene.

4. The stent of claim 2, wherein the channel wall is comprised of at least one layer of a channel material and wherein the channel is positioned within the covering.

5. The stent of claim 4, wherein the channel material allows controlled release of the biologically active material.

6. The stent of claim 4, wherein the channel material is selected from the group consisting of poly(L-lactic acid), poly(lactic acid-co-glycotic acid), polyether, polyurethane, and silicone.

7. The stent of claim 2, wherein the channel is positioned within the covering.

8. The stent of claim 7, wherein the channel is positioned entirely within the covering.

9. The stent of claim 7, wherein at least a portion of the channel wall comprises a portion of the exterior surface of a strut.

10. The stent of claim 7, wherein the covering is disposed over the exterior surface of the stent sidewall.

11. The stent of claim 7, wherein the covering is disposed over the interior luminal surface of the stent sidewall.

12. The stent of claim 7, wherein the covering is comprised of two or more layers of covering material and wherein the channel is positioned between two layers.

13. The stent of claim 1, wherein at least a portion of the stent sidewall is formed by the channel, and wherein the channel wall is comprised of at least one layer of a channel material.

14. The stent of claim 13, wherein at least one of the struts is fused to the channel wall.

15. The stent of claim 13, wherein at least one of the struts is woven with the channel.

16. The stent of claim 13, wherein the struts and channel are covered with a covering material.

17. The stent of claim 13, wherein the channel material is selected from the group consisting of poly(L-lactic acid), poly(lactic acid-co-glycotic acid), polyether, polyurethane, and silicone.

18. The stent of claim 1, wherein the channel is positioned parallel to a longitudinal axis of the stent.

19. The stent of claim 1, wherein the channel is positioned along a circumference of the stent.

20. The stent of claim 1, wherein the channel is cylindrical shaped.

21. The stent of claim 1, wherein the channel has an oblong-shaped cross section.

22. The stent of claim 1, wherein the channel has a square-shaped cross section.

23. The stent of claim 1, wherein the channel has a star-shaped cross section.

24. The stent of claim 1, wherein the inner diameter of the channel is between about 10 μ

m and about 1 mm.

25. The stent of claim 24, wherein the inner diameter of the channel is between about 50 μ

m and about 500 μ

m.

26. The stent of claim 1, wherein the channel has at least one opened end.

27. The stent of claim 26, wherein a tube having an end, is positioned in the channel, and wherein the end of the tube protrudes from the opened end of the channel.

28. A method for making an implantable stent prosthesis having (1) a sidewall having a portion comprising a plurality of struts defining a plurality of openings, each strut having an exterior surface, and (2) at least one channel for containing a biologically active material, wherein the channel is attached to the sidewall, and the channel comprises a channel space defined by a single continuous channel wall, wherein the method comprises the steps of:

(a) obtaining the stent covered by a layer of a stent covering material;

(b) placing at least one tube or mandrel in contact with the covering material,

(c) surrounding the tube or mandrel with the covering material, and

(d) forming the channel so that the channel is located within the covering material and the single continuous channel wall surrounds the tube or mandrel, and wherein the channel has two open ends.

29. The method of claim 28, wherein the channel is formed by exposing the covering material to a treatment selected from the group consisting of heat treatment, chemical treatment and treatment with an adhesive.

30. The method of claim 29, wherein the biologically active material is introduced into the channel by migration of the biologically active material.

31. The method of claim 28, wherein the channel is located entirely within the covering material.

32. The method of claim 28, which further comprises sealing one of the open ends of the channel by exposing the end to a treatment selected from the group consisting of heat treatment, chemical treatment and treatment with an adhesive.

33. The method of claim 28, which further comprises the steps of:

(e) removing the tube or mandrel from the channel; and

(f) introducing a biologically active material into the channel.

34. The method of claim 33, which further comprises the step of sealing at least open end of the channel by exposing the end to a treatment selected from the group consisting of heat treatment, chemical treatment and treatment with an adhesive.

35. The method of claim 33, wherein the tube is hollow and is placed in contact with the covering material in a manner such that an end of the tube protrudes from one of the open ends of the channel, and the biologically active material is introduced into the channel by injection of the biologically active material into the protruding end of the hollow tube.

36. The method of claim 33, wherein the biologically active material is introduced into the channel by diffusion of the biologically active material.

37. The method of claim 28, which further comprises covering the tube or mandrel with a channel material before placing the tube or mandrel in contact with the covering material.

38. The method of claim 28 wherein the covering material is selected from the group consisting of silicones, polyurethanes, thermoplastic elastomers, ethylene vinyl acetate copolymers, polyolefin elastomers, EPDM rubbers, polytetrafluoroethylene and expanded polytetrafluoroethylene.

39. The method of claim 28, wherein the mandrel is comprised of a biologically active material.

40. A method of treating an afflicted area of a surface of a body lumen comprising:

(a) implanting into the body lumen a stent prosthesis having (1) a sidewall having a portion comprising a plurality of struts defining a plurality of openings, each strut having an exterior surface, and (2) at least one channel attached to the sidewall, wherein the channel comprises a channel space defined by a single continuous channel wall, and the channel contains a biologically active material; and

(b) delivering the biologically active material to an afflicted area.

41. The method of claim 40 wherein the biologically active material is delivered by squeezing the biologically active material out of the channel.

42. The method of claim 40 wherein the biologically active material is delivered by allowing the biologically active material to diffuse out of the channel.

43. The method of claim 40 wherein the biologically active material is delivered by allowing the biologically active material to migrate out of the channel.