Coated implantable medical device method

• US 7,867,275 B2
• Filed: 09/01/2006
• Issued: 01/11/2011
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated)
• Inventors: Kozma, Thomas G., Bates, Brian L., Fearnot, Neal E., Ragheb, Anthony O., Voorhees, William D. III
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US11/515,395
• Publication Number:
  US 20070050010A1
• Time in Patent Office: 1,593 Days
• Field of Search: 623/1.11, 623 142- 143
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/885 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
• 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 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61K 51/1282 Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
• CPC Class Codes: A61L 2300/256 Antibodies, e.g. immunoglobulins, vaccines
• 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 2300/608 having two or more layers
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/106 Inorganic materials other than carbon
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• 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: A61L 33/022 Metal or alloys
• CPC Class Codes: A61N 5/1002 : Intraluminal radiation therapy
• CPC Class Codes: C08L 65/04 : Polyxylenes

Abstract

A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, and merely by condensation of a monomer vapor.

Claims

1. A method of locally delivering a bioactive agent within a body vessel, the method comprising the steps of:

(a) inserting an expandable medical device into the vascular system of a patient, the medical device comprising

(i) an expandable stent having at least one surface and being composed of a base material;

(ii) at least one coating layer comprising a bioabsorbable polymer posited in contact with the at least one surface of the stent;

(iii) at least one layer of a first bioactive material posited over the at least one coating layer;

(iii) at least one porous layer composed of a polymer posited over the first bioactive material layer, wherein the polymer is a polyurethane polymer; and

(b) radially expanding the medical device within the body vessel to bring tissue in contact with the device, delivering the bioactive agent to the tissue.

2. The method of claim 1, wherein the base material is a biocompatible metal.

3. The method of claim 1, wherein the base material is selected from the group consisting of stainless steel, nickel, silver, platinum, gold, titanium, tantalum, iridium, tungsten, Nitinol, and inconel.

4. The method of claim 1, wherein the base material is Nitinol.

5. The method of claim 1, wherein the bioactive material includes at least one of:

heparin, covalent heparin, a thrombin inhibitor, hirudin, hirulog, argatroban, D-phenylalanyl-L-poly-L-arginyl chloromethyl ketone, an antithrombogenic agent, urokinase, streptokinase, a tissue plasminogen activator, a thrombolytic agent, a fibrinolytic agent, a vasospasm inhibitor, a calcium channel blocker, a nitrate, nitric oxide, a nitric oxide promoter, a vasodilator, an antimicrobial agent, an antibiotic, aspirin, ticlopidine, a glycoprotein IIb/IIIa inhibitor, an inhibitor of surface glycoprotein receptors, an antiplatelet agent, colchicines, an antimitotic, a microtubule inhibitor, dimethyl sulfoxide, a retinoid, an antisecretory agent, cytochalasin, an actin inhibitor, a remodeling inhibitor, deoxyribonucleic acid, an antisense nucleotide, an agent for molecular genetic intervention, methotrexate, an antimetabolite, an antiproliferative agent, tamoxifen citrate, paclitaxel, paclitaxel derivatives, anti-cancer chemotherapeutic agents, dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate, a dexamethasone derivative, an anti-inflammatory steroid, a non-steroidal anti-inflammatory agent, cyclosporine, an immunosuppressive agent, trapidal, a PDGF antagonist, angiogenin, angiopeptin, a growth hormone antagonist, a growth factor, an anti-growth factor antibody, a growth factor antagonist, dopamine, bromocriptine mesylate, pergolide mesylate, a dopamine agonist, ⁶⁰CO, ¹⁹²Ir, ³²P, ¹¹¹In, ⁹⁰Y, ^99mTC, a radiotherapeutic agent, iodine-containing compounds, barium-containing compounds, gold, tantalum, platinum, tungsten, a heavy metal functioning as a radiopaque agent, a peptide, a protein, an enzyme, an extracellular matrix component, a cellular component, captopril, enalapril, an angiotensin converting enzyme inhibitor, ascorbic acid, alpha tocopherol, superoxide dismutase, deferoxamine, a 21-amino steroid, lasaroid, a free radical scavenger, iron chelator, an antioxidant, a ¹⁴C-, ³H-, ¹³¹I-, ³²P- or ³⁶S-radiolabelled form of any of the foregoing, estrogen, a sex hormone, azidothymidine, antipolymerases, acyclovir, famciclovir, rimantadine hydrochloride, ganciclovir sodium, antiviral agents, 5-aminolevulinic acid, meta-tetrahydroxyphenylchlorin, hexadecafluoro zinc phthalocyanine, tetramethyl hematoporphyrin, rhodamine 123, photodynamic therapy agents, an IgG2 Kappa antibody against Pseudomonas aeruginosa exotoxin A and reactive with A431 epidermoid carcinoma cells, monoclonal antibody against the noradrenergic enzyme dopamine beta-hydroxylase conjugated to saporin, gene therapy agents, enalapril, or a mixture of any of these.

6. The method of claim 1, wherein the bioactive material includes at least one of paclitaxel or derivatives thereof.

7. The method of claim 6, wherein the base material is nitinol.

8. The method of claim 1, wherein the expandable stent is a coronary stent.