Expandable medical device with openings for delivery of multiple beneficial agents

• US 20060122697A1
• Filed: 03/14/2005
• Published: 06/08/2006
• Est. Priority Date: 09/20/2002
• Status: Active Grant

• Current Assignee: Innovational Holdings, LLC
• Original Assignee: Conor Medsystems Incorporated
• Inventors: Shanley, John F., Parker, Theodore L., Nguyen, Thai Minh, Litvack, Frank
• Granted Patent: US 7,758,636 B2
• Time in Patent Office: Days
• US Class Current: 623/1.420
• 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 2002/91508 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 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• 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 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• 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
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

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 can 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.

Claims

1. An expandable medical device for delivery of a beneficial agent, the device comprising:

a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter;

a first plurality of openings formed in the substantially cylindrical device containing a first beneficial agent for delivery to tissue, wherein the first beneficial agent is arranged to be delivered according to a first release curve to target a first biological process of restenosis; and

a second plurality of openings formed in the substantially cylindrical device containing a second beneficial agent for delivery to tissue, wherein the second beneficial agent is arranged to be delivered according to a second release curve different from the first release curve to target a second biological process of restenosis.

2. The expandable medical device according to claim 1, wherein the first beneficial agent is pimecrolimus and the second beneficial agent is paclitaxel.

3. The expandable medical device according to claim 1, wherein the first beneficial agent is pimecrolimus and the second beneficial agent is a limus drug.

4. The expandable medical device according to claim 3, wherein the limus drug is rapamycin.

6. The expandable medical device according to claim 1, wherein the first beneficial agent is gleevec and the second beneficial agent is paclitaxel.

7. The expandable medical device according to claim 1, wherein the first beneficial agent is PKC-412 and the second beneficial agent is paclitaxel.

8. The expandable medical device according to claim 1, wherein the first beneficial agent is gleevec and the second beneficial agent is a limus drug.

9. The expandable medical device according to claim 8, wherein the limus drug is rapamycin.

10. The expandable medical device according to claim 8, wherein the limus drug is sirolimus.

11. The expandable medical device according to claim 1, wherein the first beneficial agent is PKC-412 and the second beneficial agent is a limus drug.

13. The expandable medical device according to claim 11, wherein the limus drug is sirolimus.

14. The expandable medical device according to claim 1, wherein the first beneficial agent is CdA and the second beneficial agent is a limus drug.

15. The expandable medical device according to claim 14, wherein the limus drug is rapamycin.

17. The expandable medical device according to claim 1, wherein the first beneficial agent is arranged to be delivered with at least 40% of the drug delivered in the first 24 hours and the second beneficial agent is arranged to be delivered with less than 20% of the drug delivered in the first 24 hours.

18. The expandable medical device according to claim 1, wherein an administration period of the first beneficial agent is about 3 weeks or less and an administration period of the second beneficial agent is about 4 weeks or more.

5. (canceled)

12. (canceled)

16. (canceled)

19. A method of reducing restenosis in a body passageway, the method comprising:

positioning a tissue supporting device in a body passageway to support the tissue, the tissue supporting device containing a first and a second beneficial agent in openings in the device; and

delivering the first and second beneficial agents to tissue adjacent the tissue supporting device to treat restenosis by two different mechanisms of action.

20. The method according to claim 19, wherein the first beneficial agent is pimecrolimus and the second beneficial agent is paclitaxel.

21. The method according to claim 19, wherein the first beneficial agent is pimecrolimus and the second beneficial agent is a limus drug.

22. The method according to claim 21, wherein the limus drug is rapamycin.

24. The method according to claim 19, wherein the first beneficial agent is gleevec and the second beneficial agent is paclitaxel.

25. The method according to claim 19, wherein the first beneficial agent is PKC-412 and the second beneficial agent is paclitaxel.

26. The method according to claim 19, wherein the first beneficial agent is gleevec and the second beneficial agent is a limus drug.

27. The method according to claim 19, wherein the first beneficial agent is PKC-412 and the second beneficial agent is a limus drug.

28. The method according to claim 19, wherein the first beneficial agent is CdA and the second beneficial agent is a limus drug.

29. The method according to claim 19, wherein the first beneficial agent is delivered with at least 40% of the drug delivered in the first 24 hours and the second beneficial agent delivered with less than 20% of the drug delivered in the first 24 hours.

30. The method according to claim 19, wherein an administration period of the first beneficial agent is about 3 weeks or less and an administration period of the second beneficial agent is about 4 weeks or more.

23. (canceled)

31. An expandable medical device for delivery of a beneficial agent, the device comprising:

a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter;

a first plurality of openings formed in the substantially cylindrical device containing a first beneficial agent for delivery to tissue, wherein the first beneficial agent is arranged to be delivered according to a first release curve to target a restenosis; and

a second plurality of openings formed in the substantially cylindrical device containing a second beneficial agent for delivery to tissue, wherein the second beneficial agent is arranged to be delivered according to a second release curve different from the first release curve to target a disease other than restenosis.

32. The expandable medical device according to claim 31, wherein the first beneficial agent is insulin.

33. The expandable medical device according to claim 32, wherein the first beneficial agent is delivered with at least 40% of the drug delivered in the first 24 hours and the second beneficial agent delivered with less than 20% of the drug delivered in the first 24 hours.

34. An expandable medical device for delivery of a beneficial agent, the device comprising:

a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter;

a first beneficial agent affixed to the substantially cylindrical device and arranged to be delivered according to a first release curve to target restenosis, wherein the first beneficial agent is Pimecrolimus; and

a second beneficial agent affixed to the substantially cylindrical device and arranged to be delivered according tot a second release curve to target restenosis, wherein the second beneficial agent is paclitaxel.

35. The method according to claim 34, wherein the Pimecrolimus is delivered with at least 40% of the drug delivered in the first 24 hours and the paclitaxel is delivered with less than 20% of the drug delivered in the first 24 hours.

36. The method according to claim 34, wherein 50-300 μ

g of Pimecrolimus is delivered from a 3 mm×

16 mm expanded stent and other proportional doses are delivered from other size stents.

37. The expandable medical device according to claim 36, wherein 100-250 μ

g of Pimecrolimus is delivered from a 3 mm×

16 mm expanded stent and other proportional doses are delivered from other size stents.

38. An expandable medical device for delivery of a beneficial agent comprising:

a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter;

a first beneficial agent affixed to the substantially cylindrical device with a first and a second phase of a drug delivery matrix, the first phase formed closer to the tissue to be treated than the second phase, and the first phase having a higher drug-to-polymer ratio than the second phase, wherein the first beneficial agent is Pimecrolimus.

39. The expandable medical device of claim 38, further comprising a second beneficial agent affixed to the substantially cylindrical device.

40. The expandable medical device of claim 39, wherein the second beneficial agent is paclitaxel.

41. The method according to claim 40, wherein the Pimecrolimus is delivered with at least 40% of the drug delivered in the first 24 hours and the paclitaxel is delivered with less than 20% of the drug delivered in the first 24 hours.

42. The method according to claim 38, wherein 50-300 μ

g of Pimecrolimus is delivered from a 3 mm×

16 mm expanded stent and other proportional doses are delivered from other size stents.

43. The expandable medical device according to claim 42, wherein 100-250 μ

g of Pimecrolimus is delivered from a 3 mm×

16 mm expanded stent and other proportional doses are delivered from other size stents.