Coated medical devices for the treatment of vulnerable plaque

• US 7,195,640 B2
• Filed: 04/15/2002
• Issued: 03/27/2007
• Est. Priority Date: 09/25/2001
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Falotico, Robert, Spaltro, John
• Primary Examiner(s): Bennett; Henry
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US10/122,978
• Publication Number:
  US 20030060877A1
• Time in Patent Office: 1,807 Days
• Field of Search: 604/95.03, 604/96.01, 604/101.02, 604/103.02, 604 51- 53, 604/500, 604/890.1, 604/891.1, 623/11, 623 142- 148, 623/1.16, 623/1.15, 512/291, 512/56, 512/378, 512/466, 512/824, 512/521, 512/18, 512/456, 512/763, 512/44, 512/2, 512/93.2, 512/96.4, 424/122, 424423-424, 424/290.22
• US Class Current: 623/1.42
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/06028 by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• 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 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61F 2310/00976 Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: A61L 17/145 Coating
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 : Coatings
• CPC Class Codes: A61L 2300/608 : having two or more layers
• CPC Class Codes: A61L 27/34 : Macromolecular materials
• CPC Class Codes: A61L 29/085 : Macromolecular materials
• CPC Class Codes: A61L 31/022 : Metals or alloys
• 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 7/00 : Drugs for disorders of the blood or the extracellular fluid
• 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 27/12 : containing fluorine atoms
• CPC Class Codes: C08L 27/14 : Homopolymers or copolymers of vinyl fluoride
• CPC Class Codes: C08L 27/16 : Homopolymers or copolymers or vinylidene fluoride

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. In addition to reducing or substantially eliminating a biological organism'"'"'s reaction to the introduction of the medical device to the organism, the medical device in combination with one or more therapeutic drugs, agents and/or compounds may be utilized to treat various vascular diseases, for example, restenosis and vulnerable plaque. In the case of vulnerable plaque, one or more drugs, agents or compounds may be utilized to treat the various aspects of vulnerable plaque and these drugs, agents and/or compounds may be released with a given release profile for the most effective treatment. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Claims

1. An intraluminal medical device for the treatment of atherosclerotic vulnerable plaque comprising:

a stent configured to provide structural support for a fibrous cap of a vulnerable plaque lesion;

a biocompatible vehicle affixed to at least a portion of the stent, the biocompatible vehicle including at least one layer in direct contact with the internal surface of a vessel in which the stent is positioned;

at least one first agent in a therapeutic dosage incorporated into the biocompatible vehicle for treating the inflammation associated with the acute phase of the vulnerable plaque lesion;

at least one second agent in a therapeutic dosage incorporated into the biocompatible vehicle for treating the lipid core associated with the chronic phase of the vulnerable plaque lesion, the biocompatible vehicle being configured to release the at least one first agent faster than the at least one second agent and configured to release the at least one first agent for a shorter duration than the at least one second agent;

at least one third agent in a therapeutic dosage incorporated into the biocompatible vehicle for preventing neointimal hyperplasia caused by the placement of the stent.

2. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 1, wherein the stent is balloon expandable.

3. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 1, wherein the stent is self-expanding.

4. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 1, wherein the biocompatible vehicle comprises a polymeric coating.

5. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 4, wherein the polymeric coating comprises at least one layer configured to release the at least one first agent faster than the at least one second agent and to release the at least one first agent for a shorter duration than the at least one second agent.

6. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5, wherein the at least one first agent comprises an anti-inflammatory/inflammation blocking agent.

7. The intraluminal medical device, for the treatment of atherosclerotic vulnerable plaque according to claim 5, wherein the at least one first agent comprises an anti-proliferative agent.

8. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5, wherein the at least one first agent comprises an anti-thrombogenic agent.

9. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5, wherein the at least one first agent comprises rapamycin.

10. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5, wherein the at least one first agent comprises dexamethasone.

11. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5, wherein the at least one first agent comprises anti-inflammatory corticosteroids.

12. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5, wherein the at least one first agent comprises rapamycin derivatives.

13. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5 wherein the at least one first agent comprises rapamycin analogs.

14. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5 wherein the at least one first agent comprises a direct inhibitor of the target of rapamycin kinase (mTOR).

15. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5 wherein the at least one first agent comprises a taxane, including paclitaxel and a taxane derivative that inhibits microtubule function.

16. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5 wherein the at least one first agent comprises a cyclin dependent kinase inhibitor that will block the cell cycle.

17. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5 wherein the at least one first agent comprises a retinoid.

18. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5 wherein the at least one first agent comprises a growth factor receptor kinase inhibitor.

19. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5 wherein the at least one first agent comprises a famesyl transferase inhibitor.

20. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5 wherein the at least one first agent comprises a P38 MAP kinase inhibitor.

21. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5 wherein the at least one first agent comprises an antagonist of tumor necrosis factor.

22. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5 wherein the at least one first agent comprises a mast cell stabilizer.

23. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5 wherein the at least one first agent comprises an antioxidant.

24. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5, wherein the at least one second agent comprises a lipid lowering agent.

25. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 24, wherein the lipid lowering agent is an HMG co-enzyme reductase inhibitor or statin.

26. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 24, wherein the lipid lowering agent comprises rapamycin.

27. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5, wherein the at least one second agent comprises a protease inhibitor including a matrix metalloprotease inhibitor.

28. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5, wherein the at least one second agent comprises an antiapoptotic agent.

29. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5, wherein the at least one second agent comprises a TGFbeta agonist.

30. The intraluminal medical device for the treatment of atherosclerotic vulnerable plaque according to claim 5, wherein the at least one second agent comprises a vitronectin antagonist.