Expandable medical device for delivery of beneficial agent

• US 7,179,289 B2
• Filed: 06/07/2004
• Issued: 02/20/2007
• Est. Priority Date: 03/30/1998
• Status: Expired due to Term

• 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:
  US10/862,963
• Publication Number:
  US 20040225350A1
• Time in Patent Office: 988 Days
• Field of Search: 623/1.15, 623/1.16, 623/1.17, 623/1.34, 623/1.39, 623/1.42, 623/1.43, 623/1.46, 606/194
• 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 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir

Abstract

An expandable medical device has a plurality of elongated struts, the plurality of elongated struts being joined together to form a substantially cylindrical device. The device 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 struts includes at least one opening extending at least partially through a thickness of the strut. A beneficial agent can 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 cylindrical tube;

a plurality of substantially rigid sections interconnected to form the at least one cylindrical tube;

a plurality of ductile hinges formed between the substantially rigid sections, the ductile hinges allowing the cylindrical tube to be expanded or compressed from a first diameter to a second diameter by deformation of the ductile hinges without substantial deformation of the substantially rigid sections; and

a plurality of openings in the plurality of substantially rigid sections, the plurality of openings containing at least one beneficial agent, none of said openings located on said plurality of ductile hinges, wherein the ductile hinges are designed to deform plastically upon radial expansion or compression of the expandable medical device while the plurality of substantially rigid sections experience substantially no plastic deformation upon radial expansion or compression.

2. The expandable medical device according to claim 1, wherein said plurality of beneficial agent containing openings are non-deforming openings.

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

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

5. The expandable medical device according to claim 1, wherein a single beneficial agent containing opening is located in each of the plurality of rigid sections.

6. The expandable medical device according to claim 1, wherein a plurality of beneficial agent containing openings are located in each of the plurality of rigid sections.

7. The expandable medical device according to claim 1, wherein the plurality of substantially rigid sections and the plurality of ductile hinges are interconnected in a plurality of alternating interconnected U-shapes to form the at least one cylindrical tube.

8. The expandable medical device according to claim 7, wherein the interconnected U-shapes each include at least three substantially rigid sections and at least two ductile hinges.

9. The expandable medical device according to claim 7, wherein the interconnected U-shapes each include at least four substantially rigid sections and at least three ductile hinges.

10. The expandable medical device according to claim 7, wherein ductile hinges closer to bases of the interconnected U-shapes have a larger width than ductile hinges farther from the bases of the interconnected U-shapes.

11. The expandable medical device according to claim 7, wherein the interconnected U-shapes are asymmetrical.

12. The expandable medical device according to claim 1, wherein the ductile hinges have different widths depending on their location in the stent.

13. The expandable medical device according to claim 1, wherein a width of the ductile hinges varies depending on a position of the ductile hinge on the at least one cylindrical tube in an axial direction.

14. The expandable medical device according to claim 13, wherein a width of the ductile hinges closest to the ends of the at least one cylindrical tube is greater than a width of the ductile hinges closest to the center of the at least one cylindrical tube.

15. The expandable medical device according to claim 1, wherein the plurality of ductile hinges are sized such that a width of each of the plurality of ductile hinges closest to the ends of the at least one cylindrical tube is greater than a width of the ductile hinges closest to the center of the at least one cylindrical tube.

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

17. The expandable medical device according to claim 1, wherein said at least one cylindrical tube includes two cylindrical tubes interconnected by a bridging element.

18. The expandable medical device according to claim 17, wherein the bridging element includes at least one flexible segment and at least one substantially rigid section having a beneficial agent containing opening.

19. The expandable medical device according to claim 1, wherein the plurality of ductile hinges are tapered such that a width of each of the plurality of ductile hinges closest to the ends of the at least one cylindrical tube is greater than a width of the ductile hinges closest to the center of the at least one cylindrical tube.

20. An expandable stent comprising:

a plurality of substantially rigid sections;

a plurality of ductile hinges interconnecting the plurality of substantially rigid sections to form a cylindrical stent which is expandable from a first diameter to a second diameter by deformation of the plurality of ductile hinges without substantial deformation of the substantially rigid sections; and

a plurality of openings containing at least one beneficial agent, the openings positioned in the substantially rigid sections, none of said openings located on said plurality of ductile hinges, wherein the ductile hinges are designed to deform plastically upon radial expansion or compression of the expandable medical device while the plurality of substantially rigid sections experience substantially no plastic deformation upon radial expansion or compression.

21. The expandable stent according to claim 20, wherein said plurality of openings are non-deforming openings.

22. The expandable stent according to claim 20, wherein the plurality of openings extend through a thickness of the at least one cylindrical tube, so as to thereby define a through-opening.

23. The expandable stent according to claim 20, wherein the plurality of openings have a depth less than a thickness of the at least one cylindrical tube, so as to thereby define a recess.

24. The expandable stent according to claim 20, wherein a single beneficial agent containing opening is located in each of the plurality of rigid sections.

25. The expandable stent according to claim 20, wherein a plurality of beneficial agent containing openings are located in each of the plurality of rigid sections.

26. The expandable stent according to claim 20, wherein the plurality of substantially rigid sections and the plurality of ductile hinges are interconnected in a plurality of alternating interconnected U-shapes.

27. The expandable stent according to claim 26, wherein the plurality of alternating interconnected U-shapes form a cylindrical tube.

28. The expandable stent according to claim 26, wherein the plurality of alternating interconnected U-shapes form a helically wound band.

29. The expandable stent according to claim 26, wherein the interconnected U-shapes each include at least four substantially rigid sections and at least three ductile hinges.

30. The expandable stent according to claim 26, wherein the ductile hinges have different widths depending on their location in the interconnected U-shapes.

31. The expandable stent according to claim 30, wherein ductile hinges closer to bases of the interconnected U-shapes have a larger width than ductile hinges farther from the bases of the interconnected U-shapes.

32. The expandable stent according to claim 20, wherein a width of the ductile hinges varies depending on a position of the ductile hinge on the cylindrical stent in an axial direction.

33. The expandable stent according to claim 32, wherein a width of the ductile hinges closest to the ends of the cylindrical stent is greater than a width of the ductile hinges closest to the center of the cylindrical stent.

34. The expandable stent according to claim 20, wherein the plurality of ductile hinges are tapered such that a width of each of the plurality of ductile hinges closest to the ends of the at least one cylindrical tube is greater than a width of the ductile hinges closest to the center of the at least one cylindrical tube.