Drug-eluting stent cover and method of use

• US 7,105,018 B1
• Filed: 12/30/2002
• Issued: 09/12/2006
• Est. Priority Date: 12/30/2002
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Hossainy, Syed, Jacobs, James, Limon, Timothy A., Yip, Philip S., Becker, Jon
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/334,034
• Time in Patent Office: 1,352 Days
• Field of Search: 623 111- 144
• 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 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0071 breakable or frangible
• CPC Class Codes: Y10S 623/903 Blood vessel

Abstract

An intravascular stent includes an eluting sheath fabricated from a mesh for controlled release of therapeutic drugs and for delivery of the therapeutic drugs in localized drug therapy in a blood vessel. The eluting sheath is attached to at least a portion of an outside surface area of the stent structure and is fabricated from a mesh designed to neck down in response to a radially outward directed force resulting in the uniform expansion of the stent. The eluting sheath can be loaded with at least one therapeutic drug for the release thereof at a treatment site to facilitate repair of a damaged vessel. The stent has a high degree of flexibility in the longitudinal direction, yet has adequate vessel wall coverage and radial strength sufficient to hold open an artery or other body lumen.

Claims

1. A stent system for delivery of a therapeutic agent in a body lumen, comprising:

an intravascular stent configured to contact the walls of the body lumen to maintain the patency of the vessel; and

a stent cover, the stent cover defining a delivery sheath fabricated from a mesh and placed over the stent, wherein the delivery sheath contains at least one therapeutic agent in sufficient quantities for the release thereof at the treatment site, wherein at least a portion of the mesh includes a predesigned pattern of individual mesh members that are circumferentially disposed around the stent in such a way that a majority of the individual members plastically deform and neck down along their longitudinal axes such that the individual members slide relative to one another in response to a radially outward directed force due to radial expansion of the stent.

2. The stent system of claim 1, wherein the radially outward directed force is provided by the stent expanding from a first delivery diameter to a second implanted diameter.

3. The stent system of claim 1, wherein the radially outward directed force is provided by an expandable member associated with a catheter.

4. The stent system of claim 1, wherein the radially outward directed force is provided by a self-expanding stent.

5. The stent system of claim 1, wherein the stent includes a pattern of struts having a plurality of flexible cylindrical rings being expandable in a radial direction, each of the rings having a first delivery diameter and a second implanted diameter and being aligned on a common longitudinal axis.

6. The stent system of claim 5, wherein the struts have a variable radial thickness.

7. The stent system of claim 5, wherein at least one undulating link attaches each cylindrical ring to an adjacent cylindrical ring, the undulating links being positioned substantially within a cylindrical wall of the cylindrical ring.

8. The stent system of claim 5, wherein each cylindrical ring has a plurality of first peaks and second peaks, each of the peaks having a height, the second peaks being shorter than the first peaks, wherein at least one undulating link comprises at least one curved portion connected to a substantially straight portion, the substantially straight portion being substantially perpendicular to the stent longitudinal axis.

9. The stent system of claim 1, wherein the adjacent rings are connected by at least one link.

10. The stent system of claim 1, wherein the stent is formed of a metallic material.

11. The stent system of claim 10, wherein the metallic material forming the stent is taken from the group consisting essentially of stainless steel, platinum, titanium, tantalum, nickel-titanium, cobalt chromium, and alloys thereof.

12. The stent system of claim 1, wherein the therapeutic agent is selected from the group consisting essentially of antiplatelets, anticoagulants, antifibrins, antithrombins, anti-inflammatories and antiproliferatives.

13. The stent system of claim 1, wherein the therapeutic agent loading range is about 30 to 60 percent by weight.

14. The stent system of claim 1, wherein the stent cover is attached to the stent at a stent distal end and a stent proximal end so that the cover is free to stretch in a mid-cover section as the stent expands.

15. The stent system of claim 1, wherein the mesh stent cover is comprised of a polymer.

16. The stent system of claim 15, wherein the polymeric stent mesh cover is fabricated from a polymeric material selected from the group consisting of PMMA, EVAL, PBMA, PGA, PEG, HA, PEA, PGS and PLLA.

17. The stent system of claim 1, wherein the mesh stent cover is prepared in situ by weaving.

18. The stent system of claim 1, wherein the mesh stent cover is braided on the stent.

19. The stent system of claim 1, wherein the mesh stent cover is configured to neck down in response to a stent expansion of at least 400 percent.

20. The stent system of claim 1, wherein the mesh has a radial thickness that varies to conform to a variable thickness of the stent to yield a uniform outer surface profile.

21. The stent system of claim 1, wherein the mesh stent cover has an open area of more than 5 percent.

22. The mesh stent cover of claim 21, wherein the open area is within a range of about 30 percent to about 99 percent.

23. The mesh stent cover of claim 21, wherein the open area is within a range of about 50 percent to about 85 percent.

24. The stent system of claim 1, wherein the mesh stent cover deforms plastically as a side branch vessel is accessed by a catheter.

25. The stent system of claim 1, wherein the mesh cover is attached to the stent by an adhesive.

26. The stent system of claim 1, wherein the mesh cover is attached to the stent by laser bonding.

27. The stent system of claim 1, wherein the mesh includes a radiopaque element selected from the group consisting of gold and platinum.

28. The stent system of claim 1, wherein the mesh includes a therapeutically active radioactive isotope.

29. The stent system of claim 1, wherein upon expansion of the stent, the agent loaded polymeric mesh stent cover plastically deforms so that the agent loaded cover is held against the blood vessel wall by the stent structure.

30. The stent system of claim 1, wherein the agent loaded polymeric mesh stent cover is made using at least one polymeric process consisting of extrusion, injection molding, laser cutting, braiding and slip casting.

31. The stent system of claim 1, wherein the agent delivery sheath includes at least one additional layer of polymeric material as a barrier layer to further control delivery of the therapeutic agent at the treatment site.

32. The stent system of claim 1, wherein the agent delivery sheath includes at least one additional layer of hydrophilic coating.

33. The stent system of claim 1, wherein the mesh stent cover has a thickness in the range of about 0.005 to about 0.1 mm.

34. A stent system for delivery of a therapeutic agent in a blood vessel, comprising:

a pattern of struts interconnected to form a stent structure that contacts the walls of a body lumen to maintain the patency of the vessel; and

a stent cover defining a delivery sheath fabricated from a mesh with a web pattern placed over the stent being attached to at least a portion of an outside surface area of the stent structure, the stent cover configured to cooperate with the stent to accomplish controlled and uniform expansion of the stent, wherein the stent cover is comprised of biocompatible metals and alloys.

35. The stent system of claim 34, wherein the mesh stent cover with a web pattern is wrapped around the stent structure to form a sleeve and the sleeve is attached to an outside surface of the stent structure.

36. The stent system of claim 34, wherein the mesh is fabricated from a predesigned stent pattern.

37. The stent system of claim 34, wherein the stent structure expands along a length of the stent to overcome strain.