Expandable medical device for delivery of beneficial agent

• US 8,206,435 B2
• Filed: 02/23/2009
• Issued: 06/26/2012
• Est. Priority Date: 03/30/1998
• Status: Expired due to Fees

• Current Assignee: Conor Medsystems Incorporated, Innovational Holdings, LLC (Johnson & Johnson)
• Original Assignee: Conor Medsystems Incorporated, Innovational Holdings, LLC (Johnson & Johnson)
• Inventors: Shanley, John F., Eigler, Neal L., Park, Kinam, Edelman, Elazer R.
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): BLANCO, JAVIER G
• Application Number:
  US12/390,542
• Publication Number:
  US 20090163995A1
• Time in Patent Office: 1,219 Days
• Field of Search: 623/1.42
• US Class Current: 623/1.42
• 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 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 struts includes at least one opening extending at least partially through a thickness of the 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 substantially cylindrical, expandable medical device having a tissue facing side and a luminal side, and formed of a plurality of struts;

a plurality of cylindrical openings in the plurality of struts, the openings extending entirely through the struts from the tissue facing side of the device to the luminal side, with the cylindrical 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 cylindrical openings; and

a barrier layer asymmetrically positioned adjacent one of the surfaces of the stent provided in the plurality of cylindrical openings and the barrier layer substantially preventing fluid passage and configured to substantially prevent delivery of the beneficial agent to a first of said sides of the medical device while allowing directional delivery of the beneficial agent to a second of said sides of the medical device so that the majority of the beneficial agent is released from the through openings in a direction opposite the barrier layer when the medical device is placed in a patient.

2. The expandable medical device according to claim 1, wherein the barrier layer is positioned adjacent an inner surface of the substantially cylindrical medical device.

3. The expandable medical device according to claim 1, wherein the expandable medical device is a stent.

4. The expandable medical device according to claim 1, wherein the beneficial agent is paclitaxel.

5. The expandable medical device according to claim 1, wherein the beneficial agent is rapamycin, or an analogue or derivative thereof.

6. The expandable medical device according to claim 1, wherein the beneficial agent is a protein drug.

7. The expandable medical device according to claim 1, wherein the beneficial agent and barrier layer are arranged on top of one another in the radial direction.

8. The expandable medical device according to claim 1, wherein the beneficial agent is an anti-thrombotic agent.

9. The expandable medical device according to claim 1, wherein the beneficial agent is an anti-inflammatory agent.

10. The expandable medical device according to claim 1, wherein the beneficial agent is an antimitotic agent.

11. The expandable medical device according to claim 1, wherein the beneficial agent is an anti-platelet agent.

12. The expandable medical device according to claim 1, wherein the barrier layer is loaded in the cylindrical openings.

13. An expandable medical device comprising:

an expandable cylindrical device having a plurality of struts;

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

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

a degradable barrier layer asymmetrically positioned at the radial innermost end of the plurality of through openings, the barrier layer degrading more slowly than the beneficial agent and the barrier layer substantially preventing fluid passage and configured to substantially prevent delivery of the beneficial agent through the radial innermost end of the opening so that the majority of the beneficial agent is released from the through openings in a direction opposite the barrier layer when the medical device is placed in a patient.

14. The expandable medical device according to claim 13, wherein the barrier layer is loaded in the plurality of through openings.

15. The expandable medical device according to claim 13, wherein the beneficial agent is paclitaxel.

16. The expandable medical device according to claim 13, wherein the beneficial agent is rapamycin.

17. The expandable medical device according to claim 13, wherein the beneficial agent is a protein drug.

18. The expandable medical device according to claim 13, wherein the beneficial agent is an anti-thrombotic agent.

19. The expandable medical device according to claim 13, wherein the beneficial agent is an anti-inflammatory agent.

20. The expandable medical device according to claim 13, wherein the beneficial agent is an antimitotic agent.

21. The expandable medical device according to claim 13, wherein the beneficial agent is an anti-platelet agent.