EXPANDABLE MEDICAL DEVICE FOR DELIVERY OF BENEFICIAL AGENT

• US 20070112417A1
• Filed: 01/12/2007
• Published: 05/17/2007
• Est. Priority Date: 10/16/2000
• Status: Abandoned Application

• Current Assignee: Innovational Holdings, LLC (Johnson & Johnson)
• Original Assignee: Conor Medsystems Incorporated
• Inventors: Edelman, Elazer, Park, Kinam, Eigler, Neal, SHANLEY, John
• Application Number:
  US11/622,814
• Publication Number:
  US 20070112417A1
• Time in Patent Office: Days
• US Class Current: 623/1.160
• 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 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/003 differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• 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 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/622 Microcapsules
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• 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 35/00 Antineoplastic agents
• 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 has a plurality of elongated struts joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter. At least one of the plurality of struts includes at least one opening extending at least partially through a thickness of said strut. A beneficial agent is loaded into the opening within the strut in layers to achieve desired temporal release kinetics of the agent. Alternatively, the beneficial agent is loaded in a shape which is configured to achieve the desired agent delivery profile. A wide variety of delivery profiles can be achieved including zero order, pulsatile, increasing, decrease, sinusoidal, and other delivery profiles.

Claims

1. An expandable medical device comprising:

a plurality of elongated struts, said plurality of elongated struts joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter, said plurality of struts each having a strut width in a circumferential direction and a strut thickness in a radial direction;

at least one opening in at least one of the plurality of struts; and

at least one beneficial agent provided in the at least one opening in a plurality of layers, wherein the at least one opening comprises a plurality of openings containing the beneficial agent and a plurality of openings extending through the struts and remaining open.

2. An expandable medical device comprising:

a substantially cylindrical, expandable medical device formed of a plurality of struts;

a plurality of openings in the plurality of struts, the openings extending through the struts with the openings having a substantially constant cross section from a radially outermost surface of the strut to a radially innermost surface of the strut;

a beneficial agent provided in the plurality of openings; and

a barrier layer provided in the plurality of openings and configured to substantially prevent delivery of the beneficial agent to a first side of the medical device while allowing delivery of the beneficial agent to a second side of the medical device.

3. The expandable medical device according to claim 2, wherein the barrier layer is positioned adjacent an inner surface of the substantially cylindrical medical device.

4. The expandable medical device according to claim 2, wherein the barrier layer is coated on the device.

5. The expandable medical device according to claim 2, wherein the barrier layer is loaded in the openings.

6. The expandable medical device according to claim 2, wherein the expandable medical device is a stent.

12. The expandable medical device according to claim 2, wherein the beneficial agent is paclitaxel.

13. The expandable medical device according to claim 2, wherein the beneficial agent is rapamycin, or an analogue or derivative thereof.

14. The expandable medical device according to claim 2, wherein the beneficial agent is a protein drug.

15. The expandable medical device according to claim 2, wherein the beneficial agent and barrier layers are arranged on top of one another in the radial direction.

17. The expandable medical device according to claim 2, wherein the beneficial agent and barrier layers are arranged on top of one another in the radial direction.

19. The expandable medical device according to claim 2, wherein the beneficial agent is an anti-thrombotic agent.

21. The expandable medical device according to claim 2, wherein the beneficial agent is an anti-inflammatory agent.

23. The expandable medical device according to claim 2, wherein the beneficial agent is an antimitotic agent.

25. The expandable medical device according to claim 2, wherein the beneficial agent is an anti-platelet agent.

7. An expandable medical device comprising:

an expandable cylindrical device having a plurality of struts;

a plurality of through openings in the plurality of struts, each opening having a radial innermost end and a radial outermost end; and

a beneficial agent provided in the plurality of through openings in a plurality of degradable beneficial agent layers; and

a barrier layer provided at the radial innermost end of the plurality of through openings, the barrier layer degrading more slowly than the beneficial agent layers, and the barrier layer substantially preventing fluid passage there through.

8. The expandable medical device according to claim 7, wherein the barrier layer is loaded in the plurality of through openings.

9. The expandable medical device according to claim 7, wherein the beneficial agent is paclitaxel.

10. The expandable medical device according to claim 7, wherein the beneficial agent is rapamycin.

11. The expandable medical device according to claim 7, wherein the beneficial agent is a protein drug.

16. The expandable medical device according to claim 7, wherein the plurality of degradable beneficial agent layers are arranged on top of one another in the radial direction.

18. The expandable medical device according to claim 7, wherein the plurality of degradable beneficial agent layers are arranged on top of one another in the radial direction.

20. The expandable medical device according to claim 7, wherein the beneficial agent is an anti-thrombotic agent.

22. The expandable medical device according to claim 7, wherein the beneficial agent is an anti-inflammatory agent.

24. The expandable medical device according to claim 7, wherein the beneficial agent is an antimitotic agent.

26. The expandable medical device according to claim 7, wherein the beneficial agent is an anti-platelet agent.