Intraluminal medical devices in combination with therapeutic agents

• US 20050249775A1
• Filed: 05/18/2005
• Published: 11/10/2005
• Est. Priority Date: 12/19/2003
• Status: Active Grant

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Wyeth (Pfizer Inc.)
• Inventors: Falotico, Robert, Narayanan, Pallassana
• Granted Patent: US 8,747,881 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• 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 2300/434 of enzymes
• 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 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: C08L 27/16 Homopolymers or copolymers or vinylidene fluoride
• CPC Class Codes: C08L 27/20 Homopolymers or copolymers of hexafluoropropene

Abstract

Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism'"'"'s reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism'"'"'s reaction to the introduction of the medical device to the organism. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the formation of blood clots. The drugs, agents, and/or compounds may also be utilized to treat specific diseases, including vulnerable plaque. Therapeutic agents may also be delivered to the region of a disease site. In regional delivery, liquid formulations may be desirable to increase the efficacy and deliverability of the particular drug. Also, the devices may be modified to promote endothelialization. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned. In addition, the devices utilized to deliver the implantable medical devices may be modified to reduce the potential for damaging the implantable medical device during deployment. Medical devices include stents, grafts, anastomotic devices, perivascular wraps, sutures and staples. In addition, various polymer combinations may be utilized to control the elution rates of the therapeutic drugs, agents and/or compounds from the implantable medical devices.

Claims

1. A drug delivery device comprising:

an implantable intraluminal medical device; and

a therapeutic dosage of an agent releasably affixed to the implantable intraluminal medical device for the treatment of inflammation, the agent being released for a sustained period of time in the range from about two to about six weeks, the anti-inflammatory agent comprises analogs, derivatives and congeners that bind a high affinity cytosolic protein, FKBP 12 and posses the same pharmacologic properties as rapamycin.

2. The drug delivery device according to claim 1, wherein the agent reduces inflammatory cytokine levels in vascular tissue.

3. The drug delivery device according to claim 1, wherein the agent reduces monocyte chemotactic protein levels in vascular tissues.

4. The drug delivery device according to claim 1, wherein the agent comprises rapamycin.

5. The drug delivery device according to claim 1, wherein the intraluminal medical device comprises a stent.

6. The drug delivery device according to claim 1, wherein the intraluminal medical device comprises a stent-graft.

7. The drug delivery device according to claim 1, wherein the intraluminal medical device comprises a graft.

8. The drug delivery device according to claim 1, wherein the intraluminal medical device comprises an aneurismal repair device.

9. The drug delivery device according to claim 5, wherein the agent is incorporated in a non-erodible polymeric matrix coating affixed to the stent.

10. The drug delivery device according to claim 6, wherein the agent is incorporated in a non-erodible polymeric matrix coating affixed to the stent-graft.

11. The drug delivery device according to claim 7, wherein the agent is incorporated in a non-erodible polymeric matrix coating affixed to the graft.

12. The drug delivery device according to claim 8, wherein the agent is incorporated in a non-erodible polymeric matrix coating affixed to the aneurismal repair device.

13. A method for the treatment of inflammation associated with aneurismal disease in vessel walls comprising the controlled delivery, by release, for a sustained period of time, from an implantable medical device, of an anti-inflammatory agent in therapeutic dosage amounts, the anti-inflammatory agent comprises analogs, derivatives and congeners that bind a high affinity cytosolic protein, FKBP 12 and possesses the same pharmacologic properties as rapamycin.

14. The method for the treatment of inflammation according to claim 13, wherein the anti-inflammatory agent reduces inflammatory cytokine levels in vascular tissues.

15. The method for the treatment of inflammation according to claim 13, wherein the anti-inflammatory agent reduces monocyte chemotactic protein levels in vascular tissues.

16. The method for treatment of inflammation according to claim 13, wherein the anti-inflammatory agent comprises rapamycin.

17. An aneurismal repair device comprising:

at least one-bypass prosthesis configured to establish a fluid flow path through an aneurismal section of an artery; and

at least one anti-inflammatory agent affixed to at least a portion of the at least one-bypass prosthesis, wherein the anti-inflammatory agent comprises analogs, derivatives and/or congeners that bind a high affinity cytosolic protein, FKBP 12 and possesses the same pharmacologic properties as rapamycin.

18. The aneurismal repair device according to claim 17, wherein the agent reduces inflammatory cytokine levels in vascular tissue.

19. The aneurismal repair device according to claim 17, wherein the agent reduces monocyte chemotactic protein levels in vascular tissues.

20. The aneurismal repair device according to claim 17, wherein the agent comprises rapamycin.

21. The aneurismal repair device according to claim 17, wherein the at least one-bypass prosthesis comprises a stent.

22. The aneurismal repair device according to claim 21, wherein the at least one-bypass prosthesis further comprises a graft affixed to the stent.

23. The aneurismal repair device according to claim 17, wherein the at least one-bypass prosthesis comprises a graft.

24. The aneurismal repair device according to claim 17, wherein the agent is incorporated in a non-erodible polymeric matrix coating affixed to the at least one-bypass prosthesis.

25. An aneurismal repair device comprising:

at least one-bypass prosthesis configured to establish a fluid flow path through an aneurismal section of an artery; and

a drug delivery depot operatively associated with the at least one-bypass prosthesis, the drug delivery depot configured to deliver at least one anti-inflammatory agent, the anti-inflammatory agent comprises analogs, derivatives and congeners that bind a high affinity cytosolic protein, FKBP 12 and possesses the same pharmacologic properties as rapamycin.

26. A method for treating aneurismal disease comprising:

positioning at least one-bypass prosthesis within a vessel to establish a fluid flow path through an aneurismal section of the vessel; and

locally delivering an anti-inflammatory agent in therapeutic dosage amounts, wherein the anti-inflammatory agent comprises analogs, derivatives and congeners that bind a high affinity cytosolic protein, FKBP 12 and possesses the same pharmacologic properties as rapamycin.