Coated medical devices for the prevention and treatment of vascular disease

• US 7,419,678 B2
• Filed: 05/07/2003
• Issued: 09/02/2008
• Est. Priority Date: 05/12/2000
• Status: Expired due to Term

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.), Wyeth (Pfizer Inc.)
• Inventors: Falotico, Robert
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/431,059
• Publication Number:
  US 20030216699A1
• Time in Patent Office: 1,945 Days
• Field of Search: 424/422, 424/423, 623/1.42, 623/1.43, 623/1.44, 623/1.45, 623/1.46
• US Class Current: 424/423
• 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 2002/91541 Adjacent bands are arranged out of phase
• 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 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 31/727 Heparin; Heparan
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• 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 2300/606 Coatings
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• 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

Abstract

A drug and drug delivery system may be utilized in the treatment of vascular disease. A local delivery system is coated with rapamycin or other suitable drug, agent or compound and delivered intraluminally for the treatment and prevention of neointimal hyperplasia following percutaneous transluminal coronary angiography. The local delivery of the drugs or agents provides for increased effectiveness and lower systemic toxicity.

Claims

1. A method for the prevention of target lesion restenosis comprising the controlled delivery, by a profiled release from an intraluminal stent, of one or more compounds in therapeutic dosage amounts, wherein said profiled release comprises an increased rate of release of said one or more compounds from at least one portion proximate an end of said stent relative to a rate of release of said one or more compounds from the remainder of said stent between said ends and is provided by disposing on said at least one portion a coating that has a concentration of said one or more compounds that is greater than a concentration of said one or more compounds on the remainder of said stent between said ends.

2. The method for the prevention of target lesion restenosis according to claim 1, wherein the one or more compounds comprises rapamycin.

3. The method for the prevention of target lesion restenosis according to claim 1, wherein the one or more compounds comprises a macrocyclic triene analog of rapamycin that binds a high-affinity cytosolic protein, FKBP12.

4. The method for the prevention of target lesion restenosis according to claim 1, further comprising adding an agent to enhance tissue penetration of the one or more compounds.

5. A drug delivery device comprising:

a stent comprising first and second portions said second portion proximate at least one end of said stent; and

a polymeric coating affixed to said stent, said coating comprising a therapeutic dosage of one or more compounds for the treatment of target lesion restenosis, wherein the coating affixed to said first portion contains a first concentration of said one or more compounds and the coating affixed to said second portion contains a second concentration of said one or more compounds, and wherein said second concentration is greater than said first concentration.

6. The drug delivery device according to claim 5, wherein the one or more compounds comprises rapamycin.

7. The drug delivery device according to claim 5, wherein the one or more compounds comprises a macrocyclic triene analog of rapamycin that binds a high-affinity cytosolic protein, FKBP12.

8. The drug delivery device according to claim 5, further comprising an agent for enhancing tissue penetration of said one or more compounds.

9. A method comprising providing an intraluminal stent having two ends, and disposing upon said stent one or more compounds in therapeutic dosage amounts such that a concentration of said one or more compounds on at least one portion proximate an end of said stent is greater than a concentration of said one or more compounds between said ends.