Implantable drug delivery stents

• US 20030100865A1
• Filed: 12/09/2002
• Published: 05/29/2003
• Est. Priority Date: 11/17/1999
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Charles E. Hutchinson, John T. Santini Jr
• Inventors: Santini, John T. Jr., Hutchinson, Charles E.
• Granted Patent: US 6,656,162 B2
• Time in Patent Office: Days
• US Class Current: 604/161
• CPC Class Codes: A23L 2/52 Adding ingredients adding preservatives A23L2/44
• 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 2250/0035 differing in release or diffusion time
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 15/0031 by bursting or breaking the package, i.e. without cutting or piercing
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/005 the dosages being arranged on a cylindrical surface
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0083 Timers
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 2205/8225 using incorporated gas cartridges for the driving gas
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances

Abstract

Devices for the controlled release of one or more drugs are provided. The devices include an implantable stent, at least two reservoirs in the stent, and a release system contained in each of the at least two reservoirs, wherein the release system comprises one or more drugs for release.

Claims

1. A device for the controlled release of one or more drugs comprising:

an implantable stent;

at least two reservoirs in the stent; and

a release system contained in each of the at least two reservoirs, wherein the release system comprises one or more drugs for release.

2. The device of claim 1, where the release system provides continuous release of the one or more drugs from the at least two reservoirs.

3. The device of claim 1, wherein the release system provides pulsatile release of the one or more drugs from the at least two reservoirs.

4. The device of claim 1, wherein the release system comprises drug molecules in a matrix formed of a degradable material.

5. The device of claim 1, wherein the drug is homogeneously distributed within the release system.

6. The device of claim 1, wherein the drug is heterogeneously distributed within the release system.

7. The device of claim 1, wherein the reservoirs contains two or more layers, at least one of which comprises the release system.

8. The device of claim 1, wherein the release system further comprises a synthetic biodegradable polymer.

9. The device of claim 8, wherein the synthetic biodegradable polymer is selected from the group consisting of polyamides, polyesters, polyanhydrides, polyorthoesters, and polycarbonates.

10. The device of claim 1, wherein the release system further comprises a bioerodible hydrogel.

11. The device of claim 1, wherein the one or more drugs are in the form of a solid or gel.

12. The device of claim 1, wherein the release system further comprises at least one excipient or diluent.

13. The device of claim 1, wherein the at least two reservoirs are each covered by a reservoir cap.

14. The device of claim 13, wherein the drug is released from the reservoirs by passive means.

15. The device of claim 14, wherein the reservoir cap is formed of a material that degrades or dissolves over time.

16. The device of claim 14, wherein the reservoir cap is formed of a non-degradable material that is permeable to the one or more drugs.

17. The device of claim 13, wherein the reservoir cap comprises a polymeric material.

18. The device of claim 14, wherein at least one reservoir cap is formed of a first material and at least one other reservoir cap is formed of a second material, wherein the first material has a different degradation rate, a different dissolution rate, or a different permeability to the drug molecules compared to the second material.

19. The device of claim 14, wherein at least one reservoir cap has a first thickness and at least one other reservoir cap has a second thickness, wherein the first thickness is different from the second thickness, thereby providing different times of release of the one or more drugs from the reservoirs covered respectively by the reservoir cap having the first thickness and the reservoir cap having the second thickness.

20. The device of claim 14, wherein the reservoir cap comprises a UV-crosslinkable material.

21. The device of claim 13, wherein the drug is released from the reservoirs by active means for disintegrating or rupturing the reservoir cap.

22. The device of claim 1, wherein a first drug is in at least one of the reservoirs and a second drug is in at least one other of the reservoirs, the first drug and the second drug being different in kind or dose.

23. The device of claim 1, wherein the one or more drugs comprise a protein, a polysaccharide, or a nucleic acid.

24. The device of claim 1, wherein the one or more drugs comprise an anesthetic.

25. The device of claim 1, wherein the one or more drugs comprise an antibiotic.

26. The device of claim 1, wherein the one or more drugs comprise an anti-inflammatory agent.

27. The device of claim 1, wherein the one or more drugs comprise an anti-hypertensive agent.

28. The device of claim 1, wherein the one or more drugs comprise a chemotherapeutic agent.

29. The device of claim 1, wherein the one or more drugs comprise a hormone.

30. The device of claim 1, wherein the one or more drugs comprise an immunomodulator.

31. The device of claim 1, wherein the one or more drugs comprise an ion channel regulator.

32. The device of claim 1, wherein the one or more drugs comprise a pravastatin.

33. The device of claim 1, wherein the implantable stent is an arterial or vascular stent.

34. The device of claim 1, wherein the implantable stent is a renal stent.

35. The device of claim 1, wherein the implantable stent is a ureteric or urethral stent.

36. The device of claim 1, wherein the implantable stent is bioabsorbable.

37. The device of claim 1, wherein the implantable stent comprises a metal.