Medical devices for releasing therapeutic agent and methods of making the same

• US 8,703,168 B2
• Filed: 04/25/2008
• Issued: 04/22/2014
• Est. Priority Date: 04/25/2007
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Flanagan, Aiden, Herrmann, Robert, Merdan, Ken, Kuehling, Michael, O'Brien, Barry, Radhakishnan, Rajesh, Scheuermann, Torsten, Schewe, Scott, Singhal, Anurag, Song, Young-Ho, Timm, Mary Joe, Weber, Jan, Xu, Yixin
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): HELM, CARALYNNE E
• Application Number:
  US12/109,677
• Publication Number:
  US 20090123517A1
• Time in Patent Office: 2,188 Days
• Field of Search: None
• US Class Current: 424/423
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• 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 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/3068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir

Abstract

An implantable medical device for releasing therapeutic agent having a medical device body and a plurality of reservoir-defining structures disposed on a surface of the body. A reservoir can be defined by the reservoir-defining structures and therapeutic agent may be located in the reservoir. A cover may extend over the reservoir so that the therapeutic agent is released from the reservoir when the medical device implanted. Methods for making the medical device may also include providing a medical device body, positioning a plurality of reservoir-defining structures on a surface of the body to form a reservoir, loading therapeutic agent into the reservoir, and covering the reservoir so that the therapeutic agent may release when the medical device is implanted. Alternatively, the reservoir may be covered with a cover and an opening formed in the cover so that the therapeutic agent may release when the medical device is implanted.

Claims

1. A method for making an implantable medical device for releasing therapeutic agent, comprising:

providing a medical device body;

positioning a plurality of reservoir-defining structures on a surface of the body to form at least one reservoir defined by the reservoir-defining structures;

loading therapeutic agent into the reservoir; and

moving a portion of at least one of the plurality of reservoir-defining structures from a first position to a second position so as to cover the reservoir almost completely such that an opening exists for the reservoir so that the therapeutic agent is released when the medical device is implanted,

wherein the portion of the at least one of the plurality of reservoir-defining structures is moved after the therapeutic agent is loaded.

2. The method of claim 1, wherein the reservoir-defining structures comprise a plurality of columns extending upwardly from the surface of the body, the columns forming walls of the reservoirs.

3. The method of claim 2, wherein the surface of the body forms a bottom surface for each reservoir.

4. The method of claim 2 wherein the reservoir-defining structures comprise a plurality of dividers formed by the columns.

5. The method of claim 2 wherein the reservoir-defining structures comprise a plurality of plates formed by the columns.

6. The method of claim 1 wherein the opening is between about one and one-hundred nanometers.

7. The method of claim 1 wherein the portion is a thermal shape memory alloy.

8. The method of claim 1, wherein the portion is a slanted portion.

9. The method of claim 8, wherein a region of the reservoir-defining structures is fatigued so as to facilitate movement of the slanted portion to the second position.

10. The method of claim 1, wherein the first position is an open position, and the second position is a final position, and

wherein when the portion is moved from the first to the second position, the portion is moved closer to the reservoir.

11. The method of claim 1, wherein the reservoir-defining structures are applied using a GLAD process.

12. The method of claim 1, wherein the medical device body is a stent.

13. A method for making an implantable medical device for releasing therapeutic agent, comprising:

providing a medical device body;

positioning a plurality of reservoir-defining structures on a surface of the body to form at least one reservoir defined by the reservoir-defining structures;

loading therapeutic agent into the reservoir;

covering the reservoir with a cover; and

forming a hole in the cover ex vivo so that the therapeutic agent releases through the opening when the medical device is implanted.

14. The method of claim 13 wherein the hole is centrally disposed.

15. The method of claim 13 wherein the hole is between about one and one-hundred nanometers.

16. The method of claim 13 wherein the cover is made from the same material as the plurality of reservoir-defining structures.

17. The method of claim 13 wherein the cover is applied using a GLAD process.

18. The method of claim 13 wherein the cover is comprised of a biocompatible coating.

19. The method of claim 13, wherein the reservoir-defining structures comprise a plurality of columns extending upwardly from the surface of the body, the columns forming walls of the reservoirs.

20. The method of claim 19, wherein the surface of the body forms a bottom surface for each reservoir.

21. The method of claim 13, wherein the reservoir-defining structures are applied using a GLAD process.

22. The method of claim 13, wherein the medical device body is a stent.

23. The method of claim 13, wherein the hole is formed by laser drilling.