Medical devices having porous regions for controlled therapeutic agent exposure or delivery

• US 7,666,179 B2
• Filed: 10/10/2006
• Issued: 02/23/2010
• Est. Priority Date: 10/10/2006
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Helmus, Michael N., Xu, Yixin, Tenney, Barron
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Mehta; Bhisma
• Application Number:
  US11/545,439
• Publication Number:
  US 20080086113A1
• Time in Patent Office: 1,232 Days
• Field of Search: 604/890.1, 604/891.1, 604/892.1, 604/19, 604/20
• US Class Current: 604/890.1
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 29/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04

Abstract

According to an aspect of the invention, implantable or insertable medical devices are provided which contain the following: (a) one or more porous regions comprising pores and (b) one or more therapeutic agents which are (i) contained within the porous region, (ii) disposed beneath the porous region, or (iii) both. Moreover, the porous regions are capable of undergoing a change in configuration, such that the pores undergo a change in configuration, upon subjecting the porous regions to activating stimuli.

Claims

1. An implantable or insertable medical device comprising:

(a) a porous region comprising pores having pore widths and (b) a therapeutic agent disposed within, beneath or both within and beneath said porous region, said porous region comprising a shape memory material capable of undergoing a change in configuration such that said pores undergo an increase or decrease in pore width upon subjecting said porous region to an activating stimulus.

2. The implantable or insertable medical device of claim 1, wherein said porous region is a metallic porous region.

3. The implantable or insertable medical device of claim 1, wherein said porous region comprises an alloy comprising nickel and titanium.

4. The implantable or insertable medical device of claim 1, wherein the increase or decrease in width comprises:

(a) contraction of said pores;

or

(b) expansion of said pores upon being subjected to said activating stimulus.

5. The implantable or insertable medical device of claim 1, wherein said porous region is a polymeric region.

6. The implantable or insertable medical device of claim 1, wherein said porous region comprises a block copolymer or a covalently cross-linked polymer network.

7. The implantable or insertable medical device of claim 1, wherein said porous region comprises a polymer network comprising tert-butyl acrylate and epoxy.

8. The implantable or insertable medical device of claim 1, wherein said porous region is formed from a solid material.

9. The implantable or insertable medical device of claim 1, wherein said porous region is formed from particles.

10. The implantable or insertable medical device of claim 1, wherein said porous region is formed from fibers.

11. The implantable or insertable medical device of claim 1, wherein said porous region is a nanoporous region.

12. The implantable or insertable medical device of claim 1, wherein said porous region comprises parallel pores.

13. The implantable or insertable medical device of claim 1, wherein said porous region comprises interconnected pores.

14. The implantable or insertable medical device of claim 1, wherein said pores decrease in width upon being subjected to said stimulus.

15. The implantable or insertable medical device of claim 1, wherein said pores increase in width upon being subjected to said stimulus.

16. The implantable or insert able medical device of claim 1, wherein said stimulus is a change in temperature.

17. The implantable or insertable medical device of claim 1, wherein said stimulus is selected from heat, electric current, pH change, pressure change, light and combinations thereof

18. The implantable or insertable medical device of claim 1, wherein said porous region is disposed over a substrate.

19. The implantable or insertable medical device of claim 18, wherein said substrate comprises a plurality of therapeutic-agent-containing depressions.

20. The implantable or insertable medical device of claim 18, wherein said substrate is a metallic substrate.

21. The implantable or insertable medical device of claim 18, wherein said substrate is a polymeric substrate.

22. The implantable or insertable medical device of claim 18, wherein said substrate is a ceramic substrate.

23. The implantable or insertable medical device of claim 18, wherein said substrate is a metallic, ceramic or polymeric stent body.

24. The implantable or insertable medical device of claim 1, wherein said device is selected from catheters, guide wires, balloons, filters, stents, grafts, stent grafts, vascular access ports, embolization devices, myocardial plugs, patches, pacemakers, pacemaker leads, left ventricular assist devices, total artificial hearts, heart valves, vascular valves, anastomosis clips and rings, and tissue engineering scaffolds.

25. The implantable or insertable medical device of claim 1, wherein said medical device is adapted for implantation or insertion into the coronary vasculature, peripheral vascular system, esophagus, trachea, colon, biliary tract, urogenital system, or brain.

26. The implantable or insertable medical device of claim 1, wherein said therapeutic agent is retained within said device.

27. The implantable or insertable medical device of claim 1, wherein said therapeutic agent is released from said device.

28. The implantable or insertable medical device of claim 27, wherein the release is selected from zero-order release, first order release, second order release, step-wise release, burst release, and combinations thereof.

29. The implantable or insertable medical device of claim 1, wherein said therapeutic agent is selected from one or more of the group consisting of anti-thrombotic agents, anti-proliferative agents, anti-inflammatory agents, anti-migratory agents, agents affecting extracellular matrix production and organization, antineoplastic agents, anti-mitotic agents, anesthetic agents, anti-coagulants, vascular cell growth promoters, vascular cell growth inhibitors, cholesterol-lowering agents, vasodilating agents, TGF-β

elevating agents, and agents that interfere with endogenous vasoactive mechanisms.

30. The implantable or insertable medical device of claim 1, further comprising an additional therapeutic agent.

31. The implantable or insertable medical device of claim 1, wherein the therapeutic agent is an immobilized therapeutic agent which is (a) within a temporary, deformed porous region, (b) immobilized beneath the porous region, or (c) positioned in both (a) and (b).

32. The implantable or insertable medical device of claim 1 wherein the porous region returns to its original shape upon removal of the activating stimulus.

33. The implantable or insertable medical device of claim 32 wherein transport of a bodily species from a bodily environment surrounding the device or catalytic products of the bodily species is (a) increased to and from the device by enlargement of the pore widths in vivo or ex vivo;

or (b) decreased by shrinkage of the pore widths in vivo or ex vivo.

34. The implantable or insertable medical device of claim 32 wherein transport of a bodily species from a bodily environment surrounding the device or catalytic products of the bodily species is (a) increased to and from the device by enlargement of the pore widths in vivo or ex vivo;

or (b) decreased by shrinkage of the pore widths in vivo or ex vivo upon being subjected to said activating stimulus.