Controlled disintegrating implantable medical devices

• US 20070055364A1
• Filed: 08/23/2005
• Published: 03/08/2007
• Est. Priority Date: 08/23/2005
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Hossainy, Syed, Gale, David, Ludwig, Florian
• Granted Patent: US 9,248,034 B2
• Time in Patent Office: Days
• US Class Current: 623/1.380
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 2300/622 Microcapsules
• 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

Abstract

Implantable medical devices for treating bodily disorders local and distally to a region of implantation are disclosed.

Claims

1. A implantable medical device comprising a body structure, at least a portion of the body structure comprising:

a plurality of particles releasably bound together by an erodible binder, the particles configured to be released from the body structure of the device due to erosion of the body structure during use of the device, wherein the released particles are adapted to treat a bodily disorder.

2. The device of claim 1, wherein the device is a stent adapted to be implanted in a bodily lumen.

3. The device of claim 1, wherein at least some of the particles comprise at least one type of active agent.

4. The device of claim 1, wherein the binder comprises an active agent.

5. The device of claim 1, wherein the binder is selected from a group consisting of a bioabsorbable polymer;

a biosoluble material;

a biopolymer;

a biostable metal;

a bioerodible metal;

a block copolymer of a bioabsorbable polymer or a biopolymer;

a bioabsorbable ceramic;

or a combination thereof.

6. The device of claim 1, wherein erosion is due to dissolution, chemical breakdown, and/or enzymatic degradation of the binder material and/or particles.

7. The device of claim 1, wherein rheological forces facilitate release of the particles.

8. The device of claim 1, wherein at least some of the released particles are adapted to be transported to a selected bodily region distal from a local region of implantation and to treat the distal region with an active agent.

9. The device of claim 1, wherein the device comprises a stent, and wherein the local region comprises a vascular region comprising a lesion and the distal region comprises vasculature distal from the lesion and/or a per-adventitial region.

10. The device of claim 1, wherein the plurality of particles comprise particles with different treatment properties.

11. The device of claim 1, wherein the plurality of particles are arranged such that selected particles of the plurality of particles are released during a selected time period or are released according to a sequence as compared to other particles.

12. The device of claim 1, wherein the plurality of particles are arranged such that selected particles of the plurality of particles are released during a selected time period or are released according to a sequence as compared to other particles, wherein the particles are selected based on treatment properties of the particles.

13. The device of claim 1, wherein the body structure comprises at least one layer comprising at least some of the particles bound together with the binder.

14. The device of claim 1, wherein properties of the binder vary spatially in the body structure of the device so as to obtain a selected rate of release of selected particles from the body structure.

15. The device of claim 1, wherein the device comprises a coating above at least some of the particles and binder, the coating configured to delay or inhibit erosion of the body structure of the device and to delay or inhibit release of particles from the body structure.

16. The device of claim 1, wherein the device comprises a bioabsorbable composite layer above at least some of the particles, the composite layer having particles mixed, dispersed, or embedded within the matrix, the composite layer configured to delay or inhibit erosion of the body structure of the device and to delay or inhibit release of particles from the body structure.

17. A method of treating a bodily disorder using an implantable medical device, comprising:

disposing an implantable medical device at an implantation bodily region, at least a portion of a body structure of the device comprising a plurality of particles releasably bound together by an erodible binder, the particles being adapted to be released from the body structure of the device due to erosion of the body structure, wherein the particles are adapted to treat a bodily disorder; and

allowing at least some of the particles to be released from the body structure of the device.

18. The method of claim 17, wherein the released particles are transported to a bodily region distal from the implantation bodily region to treat the bodily disorder at the distal region.

19. The method of claim 17, wherein the released and/or bound particles treat the bodily disorder and/or a second bodily disorder at or adjacent to the implantation bodily region.

20. The method of claim 17, wherein the device comprises a stent adapted to be implanted in a bodily lumen.

21. The method of claim 17, wherein the released particles treat the bodily disorder with an active agent that is delivered by the particles.

22. The method of claim 17, wherein the binder comprises an active agent.

23. The method of claim 18, further comprising allowing an active agent in the binder to treat a second bodily disorder at or adjacent to the implantation bodily region.

24. The method of claim 17, wherein the binder is selected from a group consisting of a bioabsorbable polymer, a biosoluble material, a biopolymer, a biostable metal, a bioerodible metal, a block copolymer, or a combination thereof.

25. The method of claim 17, wherein erosion is caused by dissolution and/or absorption of the binder material and/or particles.

26. The method of claim 17, wherein rheological forces facilitate disintegration of the body structure and release of the particles.

27. The method of claim 26, wherein the device comprises a stent, and wherein the implantation region comprises a vascular region having a lesion and the distal region comprises vasculature distal from the lesion and/or a per-adventitial region.

28. The method of claim 17, wherein selected particles of the plurality of particles are released during a selected time period or sequence as compared to other particles.

29. The method of claim 17, wherein selected particles of the plurality of particles are released during a selected time or sequence as compared to other particles, wherein the particles are selected based on treatment properties of the particles.

30. The method of claim 17, wherein a degradation rate of the binder varies spatially throughout the body structure of the device so as to obtain a selected rate of release of selected particles from the body structure.

31. A method of treating a bodily disorder using an implantable medical device, comprising:

disposing an implantable medical device at an implantation bodily region, at least a portion of a body structure of the device comprising a plurality of particles releasably bound together by an erodible binder, the particles being adapted to be released from the body structure of the device due to erosion of the body structure; and

allowing an active agent within the particles to treat a bodily disorder at or near the implantation region.

32. The method of claim 31, wherein the device comprises a stent adapted to be implanted in a bodily lumen.

33. The method of claim 31, wherein the active agent diffuses into bodily tissue at or near the implantation region to treat the bodily disorder.

34. The method of claim 33, wherein the bodily tissue comprises per adventitia.

35. A method of fabricating an implantable medical device, comprising:

applying a fluid on a predefined portion of a plurality of particles; and

allowing the fluid to releasably bind together the predefined portion of particles with a binder to form a layer comprising the particles bound together with the binder, the particles being configured to be released from the device due to erosion of the device during use, wherein the released particles are adapted to treat a bodily disorder with an active agent in the particles.

36. The method of claim 35, wherein the device comprises a stent.

37. The method of claim 35, wherein the applied fluid comprises a binder dissolved in a fluid.

38. The method of claim 35, wherein the fluid comprises a solvent that dissolves a portion of the predefined portion of particles, and wherein the binder comprises the portion of the particles dissolved by the fluid.

39. The method of claim 35, wherein allowing the fluid to releasably bind together the predefined portion of particles with a binder comprises allowing the fluid to dissolve a portion of the particles and removing all or substantially all of the fluid from the particles.

40. The method of claim 35, wherein allowing the fluid to releasably bind together the predefined portion of particles with a binder comprises allowing a binder dissolved in the fluid comprising a solvent for the binder to bind the particles together after removal of all or substantially all of the solvent from the particles and the binder.

41. The method of claim 35, further comprising applying at least one more layer of second particles bound together by a second binder over the first layer.