Polymer film for wrapping a stent structure

• US 5,637,113 A
• Filed: 12/13/1994
• Issued: 06/10/1997
• Est. Priority Date: 12/13/1994
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Tartaglia, Joseph M., Turnlund, Todd H., Loeffler, Joseph P.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/355,402
• Time in Patent Office: 910 Days
• Field of Search: 623/1, 623/11, 606/191, 606/194, 604/104, 604/106
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

The drug loaded stent includes an expandable stent structural member, and a planar sheet of polymeric material attached to the outside of the expandable stent structural member. The polymeric material is preferably bioabsorbable, and loaded or coated with a therapeutic agent or drug to reduce or prevent restenosis in the vessel being treated. The polymer material can be attached to the metal stent at one or more points, and wrapped in a coil around the stent in an unexpanded state, to uncoil and expand in diameter to substantially match the expanded diameter of the metal stent; or can be wrapped tightly around the stent structural member and attached to itself, to stretch radially when the stent structural member is expanded. In another currently preferred embodiment, a combination of a stent structural member and a polymeric film wrapping can be provided with a coating of lubricious material. The lubricious material can be polyethylene oxide, polyethylene glycol, polyethylene acetate, polyvinyl pyrrolidone, polyvinyl alcohol, polyacrylamide, hydrophilic soft segment urethanes, some natural gums, polyanhydrides or other similar hydrophilic polymers, and combinations thereof. The layer of lubricious material protects the stent from the guide or the body lumen in which the stent is inserted by providing a low friction surface over the stent.

Claims

1. A drug loaded stent, comprising:

an expandable stent structural member; and

a sheet of polymeric material having one end attached to the stent structural member and a free end, said sheet of polymeric material being wrapped in a coil about the stent, whereby said sheet of polymeric material is free to uncoil when said stent structural member is expanded, to substantially match the expansion of said stent structural member, said polymeric material being loaded with a therapeutic agent.

2. The drug loaded stent of claim 1, wherein said sheet of polymeric material is wrapped circumferentially around the stent structural member at least one time, and said sheet of polymeric material is attached to the stent structural member by adhesive.

3. The drug loaded stent of claim 1, wherein said stent structural member has a surface defining a plurality of slotted openings therethrough and a plurality of structural ribs, said sheet of polymeric material has at least one attachment tab having an aperture therethrough and a slit extending from said aperture to an outside edge of said attachment tab, said sheet of polymeric material being attached to the stent structural member by inserting said attachment tab into one said stent slotted opening and hooking said slit and said aperture of said attachment tab to a structural rib of said stent structural member, and said sheet of polymeric material is wrapped circumferentially around the stent structural member at least one time.

4. The drug loaded stent of claim 1, wherein said stent structural member has a longitudinal axis, and said sheet of polymeric material has at least one slit transverse to the axis of said stent structural member to accommodate uneven expansion of the stent structural member.

5. The drug loaded stent of claim 1, wherein said therapeutic agent is selected from the group consisting of therapeutic agents consisting of antiplatelets, antithrombins, cytostatic and antiproliferative agents.

6. The drug loaded stent of claim 1, wherein said therapeutic agent is selected from the group of therapeutic agents consisting of sodium heparin, low molecular weight heparin, hirudin, argatroban, forskolin, vapiprost, prostacyclin, prostacyclin analogues, dextran, D-phe-pro-arg-chloromethylketone, dipyridamole, glycoprotein IIb/IIIa platelet membrane receptor antibody, recombinant hirudin, thrombin inhibitor, angiopeptin, angiotensin converting enzyme inhibitors, calcium channel blockers, colchicine, fibroblast growth factor antagonists, fish oil, omega 3-fatty acid, histamine antagonists, HMG-CoA reductase inhibitor, methotrexate, monoclonal antibodies, nitroprusside, phosphodiesterase inhibitors, prostaglandin inhibitor, serotonin blockers, steroids, thioprotease inhibitors, triazolopyrimidine, PDGF antagonists, alpha-interferon, genetically engineered epithelial cells, and combinations thereof.

7. The drug loaded stent of claim 1, wherein said stent structural member is formed from a metal selected from the group of metals consisting of stainless steel, tantalum, nickel-titanium alloy, platinum-iridium alloy, gold, magnesium, an alloy consisting essentially of about 35 percent cobalt, about 35 percent nickel, about 20 percent chromium, and about 10 percent molybdenum and an alloy consisting essentially of about 50 percent cobalt, about 20 percent nickel, about 20 percent chromium, and about 10 percent molybdenum.

8. The drug loaded stent of claim 1, wherein said sheet of polymeric material has a surface defining a plurality of openings to promote rapid endothelialization.

9. The drug loaded stent of claim 1, wherein said sheet of polymeric material is coated with a layer of hydrophilic lubricious polymeric material.

10. The drug loaded stent of claim 9, wherein said lubricious material is selected from the group consisting of polyethylene oxide, polyethylene glycol, polyethylene acetate, polyvinyl pyrrolidone, polyvinyl alcohol, polyacrylamide, hydrophylic soft segment urethane, gum arabic, gum tragacanth, and combinations thereof.