Expandable medical device for delivery of beneficial agent

• US 7,179,288 B2
• Filed: 06/05/2003
• Issued: 02/20/2007
• Est. Priority Date: 03/30/1998
• Status: Expired due to Fees

• Current Assignee: Innovational Holdings, LLC
• Original Assignee: Conor Medsystems Incorporated
• Inventors: Shanley, John F.
• Primary Examiner(s): Willse; David H.
• Assistant Examiner(s): Blanco; Javier G.
• Application Number:
  US10/456,292
• Publication Number:
  US 20030199970A1
• Time in Patent Office: 1,356 Days
• Field of Search: 623/1.17, 623/1.15, 623/1.34, 623/1.39, 623/1.42, 623/1.43, 623/1.16, 623/1.46, 606/194
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• 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

An expandable medical device having a plurality of elongated struts, the plurality of elongated struts being 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, and the plurality of struts each having a strut width in a circumferential direction. 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 may be loaded into the opening within the strut. The expandable medical device may further include a plurality of ductile hinges formed between the elongated struts, the ductile hinges allowing the cylindrical device to be expanded or compressed from the first diameter to the second diameter by deformation of the ductile hinges.

Claims

1. An expandable medical device comprising:

at least one substantially cylindrical tube which is expandable from a first diameter to a second diameter, the substantially cylindrical tube having first portions which function as strain concentration portions and second portions which have a lower strain than the first portions during expansion of the tube from the first diameter to the second diameter, wherein the first portions are ductile hinges;

a plurality of openings, said plurality of openings formed in the second portions and none of said plurality of openings formed in the first portions; and

a beneficial agent retained in the openings.

2. The expandable medical device according to claim 1, wherein the first portions concentrate and localize strain away from the plurality of openings containing beneficial agent.

3. The expandable medical device according to claim 1, wherein said plurality of openings extend through a thickness of the cylindrical tube, so as to thereby define a through-opening.

4. The expandable medical device according to claim 1, wherein said plurality of openings have a depth less than a thickness of the cylindrical tube, so as to thereby define a recess.

5. The expandable medical device according to claim 1, wherein said beneficial agent includes antiproliferatives.

6. The expandable medical device according to claim 1, wherein said beneficial agent includes antithrombins.

7. The expandable medical device according to claim 1, wherein the second portions are struts which are interconnected by the first portions.

8. The expandable medical device according to claim 1, wherein the second portions are configured to be substantially non-deforming when the cylindrical tube is expanded from the first diameter to the second diameter.

9. The expandable medical device according to claim 1, wherein the beneficial agent is contained primarily within the openings and inner and outer surfaces of the substantially cylindrical tube are substantially without beneficial agent thereon.

29. The expandable medical device according to claim 2, wherein the expandable medical device is formed of Nitinol.

30. The expandable medical device according to claim 2, wherein the expandable medical device is formed of stainless steel.

31. The expandable medical device according to claim 2, wherein the beneficial agent is contained primarily within the at least one opening, and wherein inner and outer surfaces of the expandable medical device are substantially without beneficial agent thereon.

10. An expandable medical device comprising:

a plurality of elongated struts;

a plurality of ductile hinges;

at least one ductile hinge connecting together at least two of said plurality of elongated struts; and

at least one opening located in at least one of said plurality of elongated struts for loading of a beneficial agent, none of said at least opening located on said plurality of ductile hinges, wherein the beneficial agent is loaded within said at least one opening.

11. The expandable medical device according to claim 10, wherein said at least one opening comprises a plurality of openings.

12. The expandable medical device according to claim 10, wherein said at least one opening extends through a thickness of said plurality of elongated struts, so as to thereby define a through-opening.

13. The expandable medical device according to claim 10, wherein said at least one opening has a depth less than a thickness of said at least one strut, so as to thereby define a recess.

14. The expandable medical device according to claim 10, wherein said beneficial agent includes antiproliferatives.

15. The expandable medical device according to claim 10, wherein said beneficial agent includes antithrombins.

16. The expandable medical device according to claim 10, wherein said beneficial agent includes at least one of large molecules, microspheres, beneficial agents within a biodegradable polymer carrier, and cells, said at least one opening of said plurality of elongated struts forming a protected receptor for loading said beneficial agent therein.

17. The expandable medical device according to claim 10, wherein said beneficial agent defines a first beneficial agent, and further comprising a surface coating of a second beneficial agent on said expandable medical device.

18. The expandable medical device according to claim 17, wherein said first and second beneficial agents are different.

19. The expandable medical device according to claim 17, wherein said first and second beneficial agents are identical.

20. The expandable medical device according to claim 17, wherein the surface coating of said second beneficial agent covers a portion of said expandable medical device and further comprising a surface coating of a third beneficial agent covering another portion of said expandable medical device, wherein said second and third beneficial agents are different.

21. The expandable medical device according to claim 10, wherein said plurality of elongated struts and said at least one ductile hinge form an expandable cylindrical tube.

22. The expandable medical device according to claim 21, wherein the expandable cylindrical tube is connected to another cylindrical tube by a bridging element.

23. The expandable medical device according to claim 10, wherein a transition between the cross-sectional area of the struts and the cross-sectional area of the at least one ductile hinge is an abrupt transition which extends less than 10 percent of a length of a strut.

24. The expandable medical device according to claim 10, wherein the at least one ductile hinge is a curved prismatic beam having at least one curved surface.

25. The expandable medical device according to claim 10, further comprising a geometric deflection limiting feature for limiting an amount of bending of the at least one ductile hinge.

26. The expandable medical device according to claim 25, wherein the geometric deflection limiting feature includes angled side walls on opposite sides of the at least one ductile hinge which engage one another to limit deflection of the at least one ductile hinge.

27. The expandable medical device according to claim 25, wherein the geometric deflection limiting feature is a V-shaped notch.

28. The expandable medical device according to claim 10, wherein the at least one ductile hinge is designed to deform plastically upon radial expansion or compression of the expandable medical device while the elongated struts experience no plastic deformation upon radial expansion or compression.