Intravasoular stent and method

• US 5,776,184 A
• Filed: 10/09/1996
• Issued: 07/07/1998
• Est. Priority Date: 04/26/1993
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tuch, Ronald J.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): NGUYEN, TRAM A
• Application Number:
  US08/728,541
• Time in Patent Office: 636 Days
• Field of Search: 623/1, 623/11, 623/12, 606/191, 606/194, 606/195, 606/198, 600/36, 604/890.1
• US Class Current: 623/1.11
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/222 Steroids, e.g. corticosteroids
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A device for delivery of a therapeutic substance into a body lumen including a polymer in intimate contact with a drug on a stent allows the drug to be retained on the stent during expansion of the stent and also controls the administration of drug following implantation. The adhesion of the coating and the rate at which the drug is delivered can be controlled by the selection of an appropriate bioabsorbable or biostable polymer and the ratio of drug to polymer.

Claims

1. A device for delivery of a drug into a body lumen comprising:

(a) a catheter;

(b) a generally cylindrical, radially expandable stent body on the catheter; and

(c) a porous coating on the stent body comprising a polymer and a therapeutic substance in a solid/solid solution with the polymer such that the polymer has a first concentration of therapeutic substance on a portion of the coating nearest to the stent body and a second, lesser concentration of therapeutic substance on a portion of the coating away from the stent body.

2. A device according to claim 1 wherein the stent body has a metal surface.

3. A device according to claim 1 wherein the stent body has a polymeric surface.

4. A device according to claim 1 wherein the coating comprises a first coating layer comprising the therapeutic substance and the polymer and a second coating layer comprising the polymer overlaying the first coating layer.

5. A device according to claim 4 wherein the second coating layer is porous.

6. A device according to claim 4 wherein the second coating layer is more porous than the first coating layer.

7. A device according to claim 1 wherein the polymer is a bioabsorbable polymer.

8. A device according to claim 7 wherein the polymer is selected from the group consisting of poly(lactic acid), poly(lactide-co-glycolide) and poly(hydroxybutyrate-co-valerate).

9. A device according to claim 1 wherein the polymer is a biostable polymer.

10. A device according to claim 9 wherein the polymer is selected from the group consisting of silicones, polyurethanes, polyesters, vinyl homopolymers and copolymers, acrylate homopolymers and copolymers, polyethers and cellulosics.

11. A device according to claim 1 wherein the drug is selected from the group consisting of glucocorticoids, dexamethasone, dexamethasone sodium phosphate, anticoagulants, heparin, hirudin, tick anticoagulant peptide, angiopeptin, antimnitotic agents, and oligonucleotides.

12. A device according to claim 11 wherein the drug is colchicine.