Bioresorbable stent with beneficial agent reservoirs

• US 20040220660A1
• Filed: 04/08/2004
• Published: 11/04/2004
• Est. Priority Date: 02/05/2001
• Status: Abandoned Application

• Current Assignee: Innovational Holdings, LLC
• Original Assignee: Innovational Holdings, LLC
• Inventors: Shanley, John F., Parker, Theodore L., Diaz, Stephen Hunter, Litvack, Frank
• Application Number:
  US10/822,063
• Publication Number:
  US 20040220660A1
• Time in Patent Office: Days
• US Class Current: 623/1.16
• 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 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• 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 31/022 Metals or alloys
• 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

A bioresorbable drug delivery stent includes a substantially cylindrical expandable stent formed of a bioresorbable or bioresorbable material and a plurality of reservoirs or openings formed in the stent containing a beneficial agent matrix comprising a bioresorbable material and a drug. The bioresorbable stent material can be a bioresorbable metal alloy, a bioresorbable polymer, or other bioresorbable material which has sufficient structural integrity to support a lumen, such as a blood vessel lumen for a predetermined period of time. The reservoirs containing the beneficial agent matrix allow delivery of the beneficial agent, such as an anti-restenotic drug, for an administration period which is generally equal to or less than a time that the bioresorbable stent is retained in the lumen. The beneficial agent matrix may include one or more bioresorbable polymers in combination with one or more therapeutic agents or drugs and the structure of the beneficial agent matrix can be programmed to achieve a desired release profile for the drug(s) and a desired administration period.

Claims

1. A bioresorbable drug delivery stent comprising:

a substantially cylindrical expandable stent formed of a plurality of struts of a bioresorbable material;

a plurality of openings formed in the stent struts; and

a beneficial agent matrix loaded within the plurality of openings, the beneficial agent matrix comprising a bioresorbable matrix material.

2. The stent of claim 1, wherein the bioresorbable material of the stent comprises a material which degrades more slowly than the bioresorbable matrix material of the beneficial agent matrix.

3. The stent of claim 1, wherein the bioresorbable material of the stent is formed at a temperature above 100 degrees C. and the bioresorbable matrix material of the beneficial agent matrix is formed at a temperature below 100 degrees C.

4. The stent of claim 1, wherein the bioresorbable material of the stent comprises a polymer having a strength greater than the bioresorbable matrix material of the beneficial agent matrix.

5. The stent of claim 1, wherein the bioresorbable material of the stent comprises a material which is not significantly soluble by a solvent in which the bioresorbable matrix material of the beneficial agent matrix is soluble.

6. The stent of claim 1, wherein the bioresorbable material of the stent is a bioresorbable metal alloy.

7. The stent of claim 1, wherein the bioresorbable material of the stent is a bioresorbable polymer.

8. The stent of claim 1, wherein the stent is formed by laser cutting.

9. The stent of claim 1, wherein the stent is formed by molding.

10. The stent of claim 1, wherein the stent is formed by thermoforming.

11. The stent of claim 1, wherein the openings are formed by laser cutting.

12. The stent of claim 1, wherein the openings are formed by molding.

13. The stent of claim 1, wherein the openings are formed by thermoforming.

14. The stent of claim 1, wherein the bioresorbable matrix material is a bioresorbable polymer.

15. A bioresorbable drug delivery stent comprising a substantially cylindrical expandable stent body formed of a bioresorbable material and a plurality of openings formed in the stent body containing a beneficial agent matrix comprising a bioresorbable polymer and a drug, wherein the bioresorbable material of the stent body is a different material than the bioresorbable polymer of the beneficial agent matrix.

16. The stent of claim 15, wherein the bioresorbable material of the stent comprises a material which degrades more slowly than the bioresorbable polymer of the beneficial agent matrix.

17. The stent of claim 15, wherein the bioresorbable material of the stent is formed at a temperature above 100 degrees C. and the bioresorbable polymer of the beneficial agent matrix is formed at a temperature below 100 degrees C.

18. The stent of claim 15, wherein the bioresorbable material of the stent comprises a polymer having a strength greater than the bioresorbable polymer of the beneficial agent matrix.

19. The stent of claim 15, wherein the bioresorbable material of the stent comprises a material which is not significantly soluble by a solvent in which the bioresorbable polymer of the beneficial agent matrix is soluble.

20. The stent of claim 15, wherein the bioresorbable material of the stent is a bioresorbable metal alloy.

21. The stent of claim 15, wherein the bioresorbable material of the stent is a bioresorbable polymer.

22. The stent of claim 15, wherein the stent is formed by laser cutting.

23. The stent of claim 15, wherein the stent is formed by molding.

24. The stent of claim 15, wherein the stent is formed by thermoforming.

25. The stent of claim 15, wherein the openings are formed by laser cutting.

26. The stent of claim 15, wherein the openings are formed by molding.

27. The stent of claim 15, wherein the openings are formed by thermoforming.

28. A method of reducing restenosis with a bioresorbable drug delivery stent, the method comprising:

providing a drug delivery bioresorbable stent having a dosage of anti-restenotic drug arranged within a plurality of openings in the stent without coating an exterior surface of the stent with the anti-restonotic drug;

implanting the stent within an artery of a patient; and

delivering the anti-restenotic drug from the stent to the artery at a minimum release rate of 1 percent of the total dosage of the drug on the stent per day throughout an entire administration period from the time of implantation of the stent until the time that substantially all the drug is released from the stent.

29. The method of claim 28, wherein the anti-restenotic drug is contained in openings in the bioresorbable stent.

30. The method of claim 29, wherein the anti-restenotic drug is contained in the openings in a bioresorbable polymer matrix.

31. The method of claim 29, wherein the anti-restenotic drug and bioresorbable polymer matrix are delivered to the openings by delivery of a solution containing the drug and polymer matrix in a plurality of steps to create a matrix within the openings which have a concentration gradient.

32. A bioresorbable drug delivery stent comprising:

a substantially cylindrical expandable stent formed of a bioresorbable material;

a plurality of openings formed in the stent;

a beneficial agent matrix loaded within the plurality of openings, the beneficial agent matrix comprising a drug, and wherein the beneficial agent matrix is arranged such that the beneficial agent matrix does not block access of fluid from an environment surrounding the stent to the bioresorbable stent material.

33. The stent of claim 32, wherein the bioresorbable material of the stent comprises a material which degrades more slowly than the beneficial agent matrix.

34. The stent of claim 32, wherein the bioresorbable material of the stent is formed at a temperature above 100 degrees C. and the beneficial agent matrix is formed at a temperature below 100 degrees C.

35. The stent of claim 32, wherein the bioresorbable material of the stent comprises a polymer having a strength greater than the beneficial agent matrix.

36. The stent of claim 32, wherein the bioresorbable material of the stent comprises a material which is not significantly soluble by a solvent in which the beneficial agent matrix is soluble.

37. The stent of claim 32, wherein the bioresorbable material of the stent is a bioresorbable metal alloy.

38. The stent of claim 32, wherein the bioresorbable material of the stent is a bioresorbable polymer.

39. The stent of claim 32, wherein the beneficial agent matrix comprises a bioresorbable polymer.