Expandable medical device for delivery of beneficial agent

• US 7,850,727 B2
• Filed: 11/14/2005
• Issued: 12/14/2010
• Est. Priority Date: 08/20/2001
• Status: Expired due to Fees

• Current Assignee: Innovational Holdings, LLC
• Original Assignee: Innovational Holdings, LLC
• Inventors: Shanley, John F.
• Primary Examiner(s): Willse; David H
• Assistant Examiner(s): Blanco; Javier G
• Application Number:
  US11/273,916
• Publication Number:
  US 20060064157A1
• Time in Patent Office: 1,856 Days
• Field of Search: None
• 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 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 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, decreasing, sinusoidal, and other delivery profiles.

Claims

1. An expandable medical device comprising:

a plurality of struts interconnected to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter; and

a beneficial agent and carrier affixed to the plurality of struts and configured and arranged to control the release kinetics of the beneficial agent to surrounding tissue, wherein the release kinetics include an increasing agent release profile.

2. The device of claim 1, wherein the beneficial agent is paclitaxel.

3. The device of claim 2, wherein the carrier includes a barrier layer.

4. The device of claim 2, wherein the carrier is biodegradable.

5. The device of claim 2, wherein the paclitaxel and carrier are configured and arranged so that the paclitaxel is 100% discharged from the device.

6. The device of claim 1, wherein the beneficial agent is an anti-restenotic agent.

7. The device of claim 1, wherein the beneficial agent is an antithrombin.

8. The device of claim 1, wherein the beneficial agent is an anti-inflammatory.

9. The device of claim 1, wherein the carrier includes a barrier layer.

10. The device of claim 9, wherein the increasing agent release profile when plotted as cumulative agent released versus time provides a curved line with die rate of release of agent increasing over time.

11. The device of claim 1, wherein the carrier is biodegradable.

12. The device of claim 1, wherein the beneficial agent and carrier are configured and arranged so that the beneficial agent is 100% discharged from the device.

13. The device of claim 1, wherein the release kinetics of the beneficial agent to surrounding tissue includes an increasing mural agent release profile.

14. An expandable medical device comprising:

a plurality of struts interconnected to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter;

a beneficial agent and biodegradable carrier affixed to the plurality of struts and configured and arranged to control the temporal release kinetics of the beneficial agent to surrounding tissue, wherein said release kinetics include on increasing agent release profile and 100% discharge of the beneficial agent from the device.

15. The device of claim 14, wherein the beneficial agent is paclitaxel.

16. The device of claim 14, wherein the beneficial agent is an anti-restenotic agent.

17. The device of claim 14, wherein the beneficial agent is an antithrombin.

18. The device of claim 14, wherein the beneficial agent is an anti-inflammatory.

19. The device of claim 14, wherein the increasing agent release profile when plotted as cumulative agent released versus time provides a curved line with the rate of release of agent increasing over time.

20. The device of claim 14, wherein the release kinetics of the beneficial agent to surrounding tissue includes an increasing mural agent release profile.

21. A method of forming an expandable medical device comprising:

providing an expandable medical device with a plurality of struts interconnected to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter;

applying a solution of beneficial agent, biodegradable carrier layer, and solvent to the device and evaporating the solvent to form a solid beneficial agent and carrier layer; and

wherein the beneficial agent and carrier layer are configured and arranged to release the beneficial agent with an increasing agent release profile and 100% discharge of the beneficial agent from the device.

22. The device of claim 21, wherein the beneficial agent is paclitaxel.

23. The device of claim 21, wherein the beneficial agent is an anti-restenotic agent.

24. The device of claim 21, wherein the beneficial agent is an antithrombin.

25. The device of claim 21, wherein the beneficial agent is an anti-inflammatory.

26. The device of claim 21, wherein the increasing agent release profile when plotted as cumulative agent released versus time provides a curved line with the rate of release of agent increasing over time.

27. The method of claim 21, wherein forming a layer with an increasing agent release profile comprises forming a layer with art increasing mural agent release profile.

28. An expandable medical device comprising:

a plurality of struts interconnected to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter;

a beneficial agent and carrier affixed to the plurality of struts and configured and arranged to control the temporal release kinetics of the beneficial agent to surrounding tissue, wherein release kinetics include a two part release profile with both an increasing agent release profile and a decreasing agent release profile.

29. The device of claim 28, wherein the beneficial agent is paclitaxel.

30. The device of claim 28, wherein the beneficial agent is an anti-restenotic agent.

31. The device of claim 28, wherein the beneficial agent is an antithrombin.

32. The device of claim 28, wherein The beneficial agent is an anti-inflammatory.

33. The device of claim 28, wherein the two part release profile when plotted as cumulative agent released versus time provides an S-shaped line with the rate of release of agent both increasing and decreasing over time.

34. The device of claim 28, wherein the release kinetics of the beneficial agent to surrounding tissue includes an increasing mural agent release profile and a decreasing mural agent release profile.