Antithrombotic and anti-restenotic drug eluting stent

• US 8,221,496 B2
• Filed: 02/01/2007
• Issued: 07/17/2012
• Est. Priority Date: 02/01/2007
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Zhao, Jonathon Z.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/670,097
• Publication Number:
  US 20080188925A1
• Time in Patent Office: 1,993 Days
• Field of Search: 623 138- 148
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2250/0035 differing in release or diffusion time
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• 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 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

An expandable medical device includes a plurality of elongated struts, forming a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter. A plurality of different beneficial agents may be loaded into different openings within the struts for delivery to the tissue. For treatment of conditions such as restenosis, different beneficial agents are loaded into different openings in the device to address different biological processes involved in restenosis and are delivered at different release kinetics matched to the biological process treated. The different beneficial agents may also be used to address different diseases, such as restenosis and acute myocardial infarction from the same drug delivery device. In addition, anti-thrombotic agents may be affixed to at least a portion of the surfaces of the medical device for the prevention of sub-acute thrombosis.

Claims

1. An expandable intraluminal medical device comprising:

a substantially cylindrical device which is expandable from a first diameter for delivery into a vessel, to a second diameter for expanding the vessel, the substantially cylindrical device having a luminal surface and an abluminal surface, the distance between the luminal surface and the abluminal surface defining the wall thickness of the substantially cylindrical device;

at least one therapeutic agent, the therapeutic agent comprising an anti-porliferative;

a plurality of openings in the substantially cylindrical device each configured as a reservoir for holding the at least one therapeutic agent for controlled delivery into the vessel, the plurality of openings flush with the luminal surface and extending from the luminal surface to the abluminal surface; and

an anti-thrombotic agent affixed to at least one of the luminal and abluminal surfaces of the substantially clylindrical device and not the surfaces of the reservoirs such that the at least one therapeutic agent makes contact directly with the surfaces of the plurality of openings.

2. The expandable intraluminal medical device according to claim 1, wherein the one or more therapeutic agents comprises a rapamycin.

3. The expandable intraluminal medical device according to claim 2, wherein the one or more therapeutic agents comprises rapamycin analogs.

4. The expandable intraluminal medical device according to claim 2, wherein the one or more therapeutic agents comprises rapamycin derivatives.

5. The expandable intraluminal medical device according to claim 2, wherein the one or more therapeutic agents comprises rapamycin conjugates.

6. The expandable intraluminal medical device according to claim 1, wherein the one or more therapeutic agents comprises pimecrolimus.

7. The expandable intraluminal medical device according to claim 1, wherein the one or more therapeutic agents comprises paclitaxel.

8. The expandable intraluminal medical device according to claim 1, wherein the plurality of openings are partially filled with the one or more therapeutic agents.

9. The expandable intraluminal medical device according to claim 1, wherein the plurality of openings are filled with the one or more therapeutic agents.

10. The expandable intraluminal medical device according to claim 1, wherein the plurality of openings are over-filled with the one or more therapeutic agents.

11. The expandable intraluminal medical device according to claim 1, wherein the one or more therapeutic agents is incorporated into a bioabsorbable polymeric matrix.

12. The expandable intraluminal medical device according to claim 1, wherein the anti-thrombotic agent comprises heparin.

13. The expandable intraluminal medical device according to claim 1, wherein the anti-thrombotic agent comprises low-molecular weight heparin.

14. The expandable intraluminal medical device according to claim 1, wherein the anti-thrombotic agent comprises desulfated heparin.

15. The expandable intraluminal medical device according to claim 1, wherein the anti-thrombotic agent comprises fractionated heparin.

16. The expandable intraluminal medical device according to claim 1, wherein the anti-thrombotic agent comprises warfarin.

17. The expandable intraluminal medical device according to claim 1, wherein the anti-thrombotic agent comprises cilostazol.

18. The expandable intraluminal medical device according to claim 1, further comprising a combination of anti-thrombotic agents.