Expandable medical device for delivery of beneficial agent

• US 20040254635A1
• Filed: 05/27/2004
• Published: 12/16/2004
• Est. Priority Date: 03/30/1998
• Status: Abandoned Application

• Current Assignee: Innovational Holdings, LLC
• Original Assignee: Innovational Holdings, LLC
• Inventors: Eigler, Neal L., Shanley, John F.
• Application Number:
  US10/857,201
• Publication Number:
  US 20040254635A1
• Time in Patent Office: Days
• US Class Current: 623/1.17
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• 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 2250/0035 differing in release or diffusion time
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• 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 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• 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

An expandable medical device has a plurality of elongated struts joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter. At least one of the plurality of struts includes at least one opening extending at least partially through a thickness of the strut. A beneficial agent is loaded into the opening within the strut in layers to achieve desired temporal release kinetics of the agent. Alternatively, the beneficial agent is loaded in a shape which is configured to achieve the desired agent delivery profile. A wide variety of delivery profiles can be achieved including zero order, pulsatile, increasing, decrease, sinusoidal, and other delivery profiles.

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 polyanhydrides and polyorthoesters.

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.

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 13, wherein the reservoir cap comprises a polymeric material.

17. 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.

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

19. 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.

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

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

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

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

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

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

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

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

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

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