Drug-eluting stent cover and method of use

• US 7,416,558 B2
• Filed: 08/01/2006
• Issued: 08/26/2008
• Est. Priority Date: 12/30/2002
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Hossainy, Syed, Jacobs, James, Limon, Timothy A., Yip, Philip S., Becker, Jon
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/497,706
• Publication Number:
  US 20070073383A1
• Time in Patent Office: 756 Days
• Field of Search: 623 111- 148
• 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:

a stent configured to contact the wall of the body lumen to maintain the patency of the lumen; and

a stent cover, the stent cover defining a delivery sheath fabricated from a mesh and placed over the stent, wherein the mesh has a random configuration, wherein the delivery sheath contains at least one therapeutic agent in sufficient quantities for the release thereof at the treatment site, at least a portion of the mesh being configured to neck down in response to a radial outward directed force due to radial expansion of the stent, wherein the therapeutic agent loading range is about 30 to 60 percent by weight.

2. 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.

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

a stent configured to contact the wall of the body lumen to maintain the patency of the lumen; and

a stent cover, the stent cover defining a delivery sheath fabricated from a mesh and placed over the stent, wherein the mesh has a random configuration, wherein the delivery sheath contains at least one therapeutic agent in sufficient quantities for the release thereof at the treatment site, at least a portion of the mesh being configured to neck down in response to a radial outward directed force due to radial expansion of the stent, 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.

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

a stent configured to contact the wall of the body lumen to maintain the patency of the lumen; and

a stent cover, the stent cover defining a delivery sheath fabricated from a mesh and placed over the stent, wherein the mesh stent cover is configured of a random mesh, wherein the delivery sheath contains at least one therapeutic agent in sufficient quantities for the release thereof at the treatment site, at least a portion of the mesh being configured to neck down in response to a radial outward directed force due to radial expansion of the stent, wherein the mesh stent cover is fabricated from a polymeric material selected from the group consisting of PMMA, EVAL, PBMA, PGA, PEG, HA, PEA, PGS and PLLA.

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

a stent structure comprising a pattern of interconnected struts that contacts the wall of the body lumen to maintain the patency of the lumen; and

a stent cover defining a delivery sheath fabricated as a metallic or ceramic prepatterned sheet having a polymer layer disposed thereon, the stent cover being loaded with at least one therapeutic agent for the release thereof at a treatment site, the stent cover being attached to at least a portion of an outside surface area of the stent structure.

6. The stent system of claim 5, wherein the ceramic is porous.

7. The stent system of claim 5, wherein the eluting sheath is fabricated as a prepatterned woven fabric that is stretchable in two dimensions.

8. The stent system of claim 5, wherein the stent cover is wrapped around the stent structure to form a sleeve and the sleeve is attached to an outside surface area of the stent structure.

9. The stent system of claim 5, wherein the stent cover is attached to the stent structure by an adhesive.

10. 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 wall of a body lumen to maintain the patency of the lumen; 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 delivery sheath contains at least one therapeutic agent in sufficient quantities for the release thereof in the vessel, wherein the web pattern includes weakened points at selected locations to provide nonrandom breakage during expansion, the mesh cover being held against the lumen wall by the stent structure.

11. The stent system of claim 10, wherein upon expansion of the stent, the mesh stent cover is necked down.

12. The stent system of claim 10, wherein the stent cover is configured to cooperate with the stent to accomplish controlled and uniform expansion of the stent.

13. The stent system of claim 10, wherein the weakened points break when the stent expands in a range from about 150 percent to 400 percent from a stent first delivery diameter to a stent second implanted diameter.

14. The stent system of claim 10, wherein upon expansion of the stent, the stent cover breaks in a predesigned pattern.

15. A stent system for deployment in a blood vessel, comprising:

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

a stent cover defining a sheath fabricated from a mesh placed over the stent, the stent cover includes one or more positions that will break during expansion in a vessel.

16. A drug-containing stent system for deployment in a body lumen, comprising:

a mesh structure containing at least one drug, the mesh structure including individual mesh members, at least one individual mesh member including a breakable point that will break during expansion to allow unbroken mesh members to deploy against a body lumen as the mesh further expands.

17. The drug-containing stent system of claim 16, wherein the mesh structure is made of a metal or an alloy.

18. The drug-containing stent system of claim 16, wherein the mesh structure is made of a polymeric material.

19. The drug-containing stent system of claim 16, wherein at least one of the individual mesh members includes undulations.

20. The stent system of claim 16, further comprising a stent structure, and wherein the mesh structure is wrapped around the stent structure to form a sleeve and the sleeve is attached to an outside surface of the stent structure.

21. The stent system of claim 16, further comprising a stent structure, and wherein the mesh structure is configured to cooperate with the stent structure to accomplish controlled and uniform expansion of the stent structure.

22. The stent system of claim 16, wherein the mesh structure includes a polymeric mesh.

23. The stent system of claim 22, wherein the mesh is fabricated from a polymeric material selected from the group consisting of acetal copolymer, acetal homopolymer, acrylonitrile butadiene styrene, ABS and polycarbonate, nylon, polyamide, polyacrylate, polyaryl sulfone, polycarbonate, polyetherketone, polyetherimide, polyether sulfone, polyethylene terephthalate, polyimide, polyphenylene oxide, polyphenylene sulfide, polypropylene, polysulfone, polyurethane, polyvinyl chloride, and styrene acrylonitrile.

24. The stent system of claim 16, wherein the mesh structure is fabricated from a predesigned stent pattern.