Polymer film for wrapping a stent structure

• US 5,700,286 A
• Filed: 08/22/1996
• Issued: 12/23/1997
• Est. Priority Date: 12/13/1994
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Turnlund, Todd H., Tartaglia, Joseph M., Loeffler, Joseph P.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/701,405
• Time in Patent Office: 488 Days
• Field of Search: 623/1, 623/12, 604/104, 604/105, 606/191, 606/194, 606/195
• US Class Current: 623/1.15
• 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 stents.

Claims

1. A drug loaded stent, comprising:

an expandable stent structural member;

a sheet of polymeric material disposed on the stent structural member, said sheet of polymeric material being wrapped about the stent structural member at least one time to form a coil having an interior portion, an exterior portion, and an exterior end portion, said sheet of polymeric material being loaded with a therapeutic agent; and

at least one strip of elastic material, one end of said at least one strip of elastic material being attached to the exterior portion of the coil, and an opposing end of the strip of elastic material being attached to another portion of the exterior of the coil, said strip of elastic material extending across the exterior end portion of the coil, to secure the coil on the stent, and such that 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.

2. The drug loaded stent of claim 1, wherein said sheet of polymeric material is selected from the group of polymers consisting of thermoplastic and elastomeric polymers, whereby said sheet of polymeric material stretches radially when said stent structural member is expanded.

3. The drag loaded stent of claim 1, wherein said at least one strip of elastic material is heat bonded to the exterior portion of the coil.

4. The drug loaded stent of claim 1, wherein said at least one strip of elastic material has a surface defining a plurality of apertures therein.

5. The drug loaded stent of claim 1, wherein said therapeutic agent is selected from the group 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.

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

7. The drug loaded stent of claim 1, wherein said stent structural member is formed from a metal selected from the group 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 drag loaded stent of claim 1, wherein said sheet of polymeric material is coated with a layer of hydrophilic lubricious polymeric material.