Drug delivery device and method for bi-directional drug delivery

• US 7,169,179 B2
• Filed: 06/05/2003
• Issued: 01/30/2007
• Est. Priority Date: 06/05/2003
• Status: Active Grant

• Current Assignee: Microport Cardiovascular LLC
• Original Assignee: Conor Medsystems Incorporated
• Inventors: Shanley, John F., Parker, Theodore L.
• Primary Examiner(s): Robert; Eduardo C.
• Assistant Examiner(s): SWEET, THOMAS
• Application Number:
  US10/456,432
• Publication Number:
  US 20040249449A1
• Time in Patent Office: 1,335 Days
• Field of Search: 623/1.42, 623/1.43
• US Class Current: 623/1.43
• 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 2250/0068 the pharmaceutical product being in a reservoir

Abstract

A drug delivery device is provided with openings for directional delivery of a plurality of therapeutic agents to blood vessels or other lumens or organs. In particular, the invention relates to the delivery of different therapeutic agents, different quantities of therapeutic agents, or different release profiles of the same or different therapeutic agents in different directions from the drug delivery device. The invention is useful, for example, for delivering antirestenotic, antithrombotic, antiplatelet, antiproliferative, antineoplastic, immunosuppressive, angiogenic, anti-inflammatory, or antiangiogenic agents and/or vasodilators to a blood vessel. In one embodiment, antiproliferative, antineoplastic, angiogenic, antiangiogenic, anti-inflammatory, and/or antirestenotic agents are delivered to the wall of a blood vessel and antithrombotic agents, antiplatelet agents, and/or vasodilators are delivered to the lumen of a blood vessel.

Claims

1. A drug delivery device comprising:

a medical device body having an exterior surface and an interior surface;

a plurality of openings in the device body;

a first therapeutic agent and a second therapeutic agent disposed in the openings and arranged to deliver the first therapeutic agent primarily to the exterior surface and to deliver the second therapeutic agent primarily to the interior surface; and

a bioerodible barrier layer disposed in the openings at a radially intermediate position with respect to said exterior surface and said interior surface of the medical device, and wherein said first therapeutic agent is provided at a radially exterior position with respect to the barrier layer and said second therapeutic agent is provided at a radially interior position with respect to the barrier layer.

2. The device of claim 1, wherein the openings in the medical device are through openings traversing the exterior surface and the interior surface.

3. The device of claim 1, wherein the first and second therapeutic agents are selected from the group consisting of:

a) different therapeutic agents;

b) different concentrations of therapeutic agents;

c) different release profiles of therapeutic agents;

d) anti-inflammatory; and

e) combinations of a)–

d).

4. The device of claim 1, wherein the first therapeutic agent is selected from the group consisting of an angiogenic agent an anti-inflammatory agent, and an antiproliferative agent.

5. The device of claim 4, wherein the second therapeutic agent is selected from the group consisting of an antirestenotic agent, an antithrombotic agent, an antiplatelet agent, an anti-inflammatory agent, and a vasodilator.

6. The device of claim 2, wherein the through openings have a substantially uniform cross section between the interior and exterior surfaces.

7. The device of claim 1, wherein the barrier layer has a predetermined erosion time which is longer than erosion times of biodegradable matrices containing the first and second therapeutic agents.

8. The device of claim 1, wherein the first therapeutic agent is contained within a biodegradable matrix and the first therapeutic agent has a concentration variation within the matrix.

9. The device of claim 1, wherein the second therapeutic agent is contained within a biodegradable matrix and the second therapeutic agent has a concentration variation within the matrix.

10. The device of claim 1, wherein the openings are substantially non-deforming openings.

11. A drug delivery device comprising:

an exterior surface;

an interior surface;

a plurality of openings traversing said exterior surface and said interior surface, said openings having a barrier layer arranged at a radially intermediate position with respect to said exterior surface and said interior surface;

at least one first therapeutic agent in a therapeutic layer disposed at a radially exterior position with respect to said barrier layer; and

at least one second therapeutic agent in a therapeutic layer disposed at a radially interior position with respect to said barrier layer, wherein the barrier layer substantially prevents passage of the first and second therapeutic agents there through.

12. The device of claim 11, wherein the first therapeutic agent is selected from the group consisting of an angiogenic agent, an anti-inflammatory agent, and an antiproliferative agent.

13. The device of claim 12, wherein the second therapeutic agent is selected from the group consisting of an antirestenotic agent, an antithrombotic agent, an antiplatelet agent, an anti-inflammatory agent, and a vasodilator.

14. The device of claim 11, wherein the openings are substantially non-deforming openings.

15. The device of claim 11, wherein the barrier layer is bioerodible.

16. The device of claim 15, wherein the barrier has a predetermined erosion time which is longer than erosion times of biodegradable matrices containing the first and second therapeutic agents.

17. A drug delivery device comprising:

a medical device body having an exterior surface and an interior surface;

a plurality of through openings in the device body traversing the exterior surface and the interior surface;

an antirestenotic agent disposed in the openings and arranged to deliver the antirestenotic agent primarily to the exterior surface;

an ADP receptor agonist disposed in the openings and arranged to deliver the ADP receptor agonist primarily to the interior surface; and

a bioerodible barrier layer disposed at a radially intermediate position of the openings with respect to said exterior surface and said interior surface of the medical device, and wherein said first antirestenotic agent is provided at a radially exterior position with respect to the barrier layer and said ADP receptor agonist is provided at a radially interior position with respect to the barrier layer.

18. The device of claim 17, wherein the through openings have a substantially uniform cross section between the interior and exterior surfaces.

19. The device of claim 17, wherein the barrier layer has a predetermined erosion time which is longer than erosion times of biodegradable matrices containing the antirestenotic agent and the ADP receptor agonist.

20. The device of claim 17, wherein the barrier layer substantially prevents passage of the antirestenotic agent and the ADP receptor agonist there through.