Expandable medical device for delivery of beneficial agent

• US 7,160,321 B2
• Filed: 06/15/2004
• Issued: 01/09/2007
• 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:
  US10/869,209
• Publication Number:
  US 20040236408A1
• Time in Patent Office: 938 Days
• Field of Search: 623/1.34, 623/1.39, 623/1.42, 623/1.43, 623/1.46, 623/1.15, 623/1.16, 623/1.17, 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 includes elongated struts which are 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. Each of the struts has a width in a circumferential direction and a thickness. At least one of the struts includes at least one opening that extends at least partially through the strut'"'"'s thickness. A beneficial agent may be loaded into the opening within the strut. The expandable medical device may also include ductile hinges, formed between the elongated struts, which deform to allow the cylindrical device to be expanded or compressed from the first diameter to the second diameter.

Claims

1. An expandable medical device comprising:

at least one cylindrical tube;

a network of elongated struts formed in said cylindrical tube, wherein each of the elongated struts are axially displaced from adjacent struts; and

a plurality of ductile hinges formed between the elongated struts, 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;

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

2. The expandable medical device according to claim 1, wherein said at least one opening comprises a plurality of openings.

3. The expandable medical device according to claim 1, wherein said at least one opening extends through a thickness of said at least one strut, so as to thereby define a through-opening.

4. The expandable medical device according to claim 1, 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.

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 said beneficial agent includes at least one of large molecules, microspheres, beneficial agents within a biodegradable polymer carrier, or cells, said at least one opening of said at least one strut forming a protected receptor for loading said beneficial agent therein.

8. The expandable medical device according to claim 1, 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.

9. The expandable medical device according to claim 8, wherein said first and second beneficial agents are different.

10. The expandable medical device according to claim 8, wherein said first and second beneficial agents are identical.

11. The expandable medical device according to claim 8, 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.

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

13. The expandable medical device according to claim 1, wherein a transition between the cross-sectional area of the struts and the cross-sectional area of the ductile hinges is an abrupt transition which extends less than 10 percent of a length of a strut.

14. The expandable medical device according to claim 1, wherein the plurality of ductile hinges are curved prismatic beams having an arc surface and a concave surface.

15. The expandable medical device according to claim 1, further comprising a geometric deflection limiting feature for limiting an amount of bending of the ductile hinges.

16. The expandable medical device according to claim 15, wherein the geometric deflection limiting feature includes angled side walls on opposite sides of a ductile hinge which engage one another to limit deflection at ductile hinge.

17. The expandable medical device according to claim 15, wherein the geometric deflection limiting feature is a V-shaped notch.

18. The expandable medical device according to claim 1, wherein the ductile hinges are 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.

19. The expandable medical device according to claim 1, wherein the expandable medical device is formed of Nitinol.