Coated medical device

• US 20060020331A1
• Filed: 09/23/2005
• Published: 01/26/2006
• Est. Priority Date: 07/12/2002
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Burton, David G., Schaeffer, Darin G., Boatman, Scott E., Sturgeon, Jason S., Bates, Brian L., Hoffa, Michael C., Ragheb, Anthony O.
• Granted Patent: US 7,731,685 B2
• Time in Patent Office: Days
• US Class Current: 623/1.490
• 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 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0025 differing in roughness
• CPC Class Codes: A61F 2250/0026 differing in surface structures
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0081 Prosthesis for animals
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00011 Metals or alloys
• 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 2300/606 Coatings
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/08 Materials for coatings
• CPC Class Codes: A61L 29/085 : Macromolecular materials
• CPC Class Codes: A61L 29/16 : Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 29/18 : Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61L 31/14 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/1031 : Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2250/00 : Specially adapted for animals
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1029 : Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/104 : used for angioplasty
• 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 coated medical device adapted for introduction into a passage or vessel of a patient is provided. The medical device is preferably an implantable balloon with a bioactive deposited or within the balloon. The balloon can further include a hydrophilic material positioned between the balloon and a bioactive material posited on the balloon.

Claims

1. An implantable medical device comprising:

an expandable balloon structure comprising a bioactive material disposed on at least a portion of the balloon structure.

2. The implantable medical device of claim 1, wherein the expandable balloon structure comprises an expandable outer surface;

wherein the medical device is configured as a portion of a catheter, and the bioactive material is disposed on the expandable outer surface of the expandable balloon structure.

3. The implantable medical device of claim 2, wherein the medical device comprises about 0.2 μ

g to about 20 μ

g of the bioactive material per square mm of surface area of the expandable outer surface of the expandable balloon structure.

4. The implantable medical device of claim 1, wherein the bioactive material comprises paclitaxel;

wherein the expandable balloon structure comprises an expandable outer surface and wherein between about 0.2 μ

g and 20 μ

g of paclitaxel per square mm is disposed on the expandable outer surface of the expandable balloon structure.

5. The implantable medical device of claim 1, wherein the bioactive material is selected from the group consisting of:

an immunosuppressive agent, an antimetabolite agent, an antiproliferative agent, an anti-cancer chemotherapeutic agent, an antimitotic agent, a microtubule inhibitor, a smooth muscle cell inhibitor, a collagen inhibitor, a cell cycle inhibitor, an actin inhibitor, a remodeling inhibitor, a fibroblast growth factor (FGF) antagonist, a growth hormone agonist, a thrombolytic agent, an antiplatelet agent, an antithrombogenic agent, an anti-coagulant agent, a histamine antagonist, a cholesterol reducing agent, an inhibitor of HMG CoA reductase, a vasodilator, a calcium channel blocker, a nitrate, a nitric oxide promoter, a dopamine agonist, an antimicrobial agent, an antibiotic agent, an agent for molecular genetic intervention, deoxyribonucleic acid, an anti-sense nucleotide, a surface glycoprotein receptor, a peptide, a protein, an enzyme, an extracellular matrix component, a cellular component, a monoclonal antibody, a phosphodiesterase inhibitor, a steroid, a prostaglandin inhibitor, a PDGF antagonist, a serotonin blocker, a thioprotease inhibitor, an angiotensin converting enzyme (ACE) inhibitor, an anti-inflammatory agent, a tissue plasminogen activator, a free radical scavenger, an iron chelator, an antioxidant, a radio-therapeutic agent, a radiopaque agent, and a radiolabelling agent.

6. The implantable medical device of claim 1, wherein the bioactive material is selected from the group consisting of:

paclitaxel, rapamycin, methotrexate, cytochalasin, colchicine, cyclosporine, the protein product of the retinoblastoma tumor suppressor gene, angiopeptin, a vascular endothelial growth factor (VEGF), urokinase, streptokinase, heparin, hirudin, aspirin, ticlopidine, argatroban, D-phenylalanyl-L-poly-L-arginyl chloromethyl ketone, an omega 3-fatty acid, Lovastatin, nitric oxide, Estrogen, Dopamine, bromocriptine mesylate, pergolide mesylate, streptomycin, erythromycin, vancomycin, forskolin, vapiprost, prostaglandin, prostacyclin, Seramin, triazolopyrimidine, alpha interferon, Captopril®

, Cilazapril®

, Lisinopril®

, dexamethasone, ⁶⁰Co, ¹⁹²Ir, ³²P, ¹¹¹In, ⁹⁰Y, ⁹⁹mTc, an iodine-containing radiopaque compound, barium-containing radiopaque compound, gold, tantalum, platinum, tungsten, a ¹⁴C-radiolabelling compound, a ³H-radiolabelling compound, a ¹³¹I-radiolabelling compound, a ³²P-radiolabelling compound, a ³⁶S radiolabelling compound, ascorbic acid, alphatocopherol, superoxide dismutase, deferoxyamine, a 21-aminosteroid (lasaroid), dipyridamole, nitroprusside and analogs, derivatives and pharmaceutically acceptable salts thereof.

7. The implantable medical device of claim 1, wherein the bioactive material is selected from the group consisting of paclitaxel, paclitaxel analogs, paclitaxel derivatives and pharmaceutically acceptable salts thereof.

8. The implantable medical device of claim 1, wherein the bioactive material is selected from the group consisting of rapamycin, rapamycin analogs, rapamycin derivatives and pharmaceutically acceptable salts thereof.

9. The implantable medical device of claim 1, wherein the expandable balloon structure comprises an expandable outer surface;

the medical device further comprising a first coating layer posited on at least a portion of the expandable outer surface of the expandable balloon structure, where the first coating layer comprises a hydrophilic material, and wherein the bioactive material is posited on at least a portion of the first coating layer.

10. The implantable medical device of claim 9, where the bioactive material is a lipophilic material.

11. The implantable medical device of claim 1, wherein the expandable balloon structure comprises an expandable outer surface;

the medical device further comprising a first coating layer posited on at least a portion of the expandable outer surface of the expandable balloon structure and a second coating layer posited on at least a portion of the first coating layer, where the first coating layer comprises a hydrophilic material and the second coating layer comprises a lipophilic material and the bioactive material.

12. The implantable medical device of claim 1, wherein the expandable balloon structure comprises an expandable outer surface;

the medical device further comprising a first coating layer posited on at least a portion of the expandable outer surface of the expandable balloon structure and a second coating layer posited on at least a portion of the first coating layer, where the first coating layer comprises the bioactive material and the second coating layer comprises a hydrophilic material.

13. The implantable medical device of claim 1, wherein the expandable balloon structure comprises an expandable outer surface;

the medical device further comprising a coating layer posited on at least a portion of expandable outer surface, the coating layer comprising the bioactive material and a material selected from the group consisting of;

a polyamide, polyethylene terephthalate, polyurethane, a polyester, a polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, polylactic acid, polyglycolic acid, a polyanhydride, polycaprolactone, polyhydroxybutyrate valerate, a biodegradable polymer, a protein, an extracellular matrix component, collagen, fibrin, a biologic agent, PEBAX, polyethylene, irradiated polyethylene and or a mixture or copolymer thereof.

14. The implantable medical device of claim 1, wherein the expandable balloon structure comprises an expandable outer surface;

the medical device further comprising a first coating layer posited on at least a portion of the expandable outer surface of the expandable balloon structure and a second coating layer posited on at least a portion of first coating layer, where the first coating layer comprises the bioactive material and the second coating layer comprises a material selected from the group consisting of;

a polyamide, polyethylene terephthalate, polyurethane, a polyester, a polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, polylactic acid, polyglycolic acid, a polyanhydride, polycaprolactone, polyhydroxybutyrate valerate, a biodegradable polymer, a protein, an extracellular matrix component, collagen, fibrin, a biologic agent, PEBAX, polyethylene, irradiated polyethylene and or a mixture or copolymer thereof.

15. The implantable medical device of claim 1, wherein the balloon structure comprises a biocompatible polymeric material and the bioactive material.

16. The implantable medical device of claim 1, wherein the balloon structure comprises a material selected from the group consisting of:

a polyamide, polyethylene terephthalate, polyurethane, a polyester, a polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, polylactic acid, polyglycolic acid, a polyanhydride, polycaprolactone, polyhydroxybutyrate valerate, a biodegradable polymer, a protein, an extracellular matrix component, collagen, fibrin, a biologic agent, PEBAX, polyethylene, irradiated polyethylene and or a mixture or copolymer thereof.

17. An implantable medical device comprising:

an expandable balloon structure having an outer surface;

a bioactive material releasably attached to least a portion of the expandable balloon;

wherein the bioactive is selected from the group consisting of paclitaxel, paclitaxel analogs, paclitaxel derivatives, rapamycin, rapamycin analogs, rapamycin derivatives and pharmaceutically acceptable salts thereof.

18. The implantable medical device of claim 17, wherein the expandable balloon further comprises a first coating layer posited on the outer surface of the expandable balloon, wherein the first coating layer comprises the bioactive material, and a second coating layer posited on at least a portion the first coating layer, wherein the second coating layer comprises a biocompatible polymeric material.

19. The implantable medical device of claim 17, wherein the expandable balloon further comprises a first coating layer posited on the outer surface of the expandable balloon, wherein the first coating layer comprises a biocompatible polymeric material, and a second coating layer posited on at least a portion the first coating layer, wherein the second coating layer comprises the bioactive material.

20. An implantable medical device comprising:

an expandable balloon structure having an outer surface and comprising about 0.2 μ

g to about 20 μ

g of a bioactive material disposed per square mm of the outer surface;

a first coating layer posited on at least a portion of the outer surface of the outer surface of the expandable balloon; and

a second coating layer posited on at least a portion of the first coating layer;

wherein the medical device is configured as a portion of a catheter;

wherein the bioactive material is selected from the group consisting of;

an immunosuppressive agent, antimetabolite agent, an antiproliferative agent, an anti-cancer chemotherapeutic agent, an antimitotic agent, microtubule inhibitor, a smooth muscle cell inhibitor, a collagen inhibitor, a cell cycle inhibitor, an actin inhibitor, a remodeling inhibitor, a fibroblast growth factor (FGF) antagonist, a growth hormone agonist, a thrombolytic agent, an antiplatelet agent, an antithrombogenic agent, an anti-coagulant agent, a histamine antagonist, a cholesterol reducing agent, an inhibitor of HMG CoA reductase, a vasodilator, a calcium channel blocker, a nitrate, a nitric oxide promoter, a dopamine agonist, an antimicrobial agent, an antibiotic agent, an agent for molecular genetic intervention, deoxyribonucleic acid, an anti-sense nucleotide, a surface glycoprotein receptor, a peptide, a protein, an enzyme, an extracellular matrix component, a cellular component, a monoclonal antibody, phosphodiesterase inhibitors, a steroid, a prostaglandin inhibitor, a PDGF antagonist, a serotonin blocker, a thioprotease inhibitor, an angiotensin converting enzyme (ACE) inhibitor, an anti-inflammatory agent, a tissue plasminogen activator, a tissue plasminogen activator, a free radical scavenger, an iron chelator, an antioxidant, a radio-therapeutic agent, a radiopaque agent, and a radiolabelling agent;

wherein the balloon structure comprises one or more materials selected from the group consisting of;

paclitaxel, rapamycin, methotrexate, cytochalasin, colchicine, cyclosporine, the protein product of the retinoblastoma tumor suppressor gene, angiopeptin, a vascular endothelial growth factor (VEGF), urokinase, streptokinase, heparin, hirudin, aspirin, ticlopidine, argatroban, D-phenylalanyl-L-poly-L-arginyl chloromethyl ketone, an omega 3-fatty acid, Lovastatin, nitric oxide, Estrogen, Dopamine, bromocriptine mesylate, pergolide mesylate, streptomycin, erythromycin, vancomycin, forskolin, vapiprost, prostaglandin, prostacyclin, Seramin, triazolopyrimidine, alpha interferon, Captopril®

, Cilazapril®

, Lisinopril®

, dexamethasone, ⁶⁰Co, ¹⁹²Ir, ³²P, ¹¹¹In, ⁹⁰Y, ⁹⁹mTc, an iodine-containing radiopaque compound, barium-containing radiopaque compound, gold, tantalum, platinum, tungsten, a ¹⁴C-radiolabelling compound, a ³H-radiolabelling compound, a ¹³¹I-radiolabelling compound, a ³²P-radiolabelling compound, a ³⁶S radiolabelling compound, ascorbic acid, alphatocopherol, superoxide dismutase, deferoxyamine, a 21-aminosteroid (lasaroid), dipyridamole, nitroprusside, a polyamide, polyethylene terephthalate, polyurethane, a polyester, a polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, polylactic acid, polyglycolic acid, a polyanhydride, polycaprolactone, polyhydroxybutyrate valerate, a biodegradable polymer, a protein, an extracellular matrix component, collagen, fibrin, a biologic agent, PEBAX, polyethylene, irradiated polyethylene, and copolymers, mixtures, analogs, derivatives and pharmaceutically acceptable salts thereof; and

wherein the first coating layer comprises a material selected from the group consisting of;

paclitaxel, rapamycin, methotrexate, cytochalasin, colchicine, cyclosporine, the protein product of the retinoblastoma tumor suppressor gene, angiopeptin, a vascular endothelial growth factor (VEGF), urokinase, streptokinase, heparin, hirudin, aspirin, ticlopdine, argatroban, D-phenylalanyl-L-poly-L-arginyl chloromethyl ketone, an omega 3-fatty acid, Lovastatin, nitric oxide, Estrogen, Dopamine, bromocriptine mesylate, pergolide mesylate, streptomycin, erythromycin, vancomycin, forskolin, vapiprost, prostaglandin, prostacyclin, Seramin, triazolopyrimidine, alpha interferon, Captopril®

, Cilazapril®

, Lisinopril®

, dexamethasone, ⁶⁰Co, ¹⁹²Ir, ³²P, ¹¹¹In, ⁹⁰Y, ⁹⁹mTc, an iodine-containing radiopaque compound, barium-containing radiopaque compound, gold, tantalum, platinum, tungsten, a ¹⁴C-radiolabelling compound, a ³H-radiolabelling compound, a ¹³¹I-radiolabelling compound, a ³²P-radiolabelling compound, a ³⁶S radiolabelling compound, ascorbic acid, alphatocopherol, superoxide dismutase, deferoxyamine, a 21-aminosteroid (lasaroid), dipyridamole, nitroprusside, a polyamide, polyethylene terephthalate, polyurethane, a polyester, a polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, polylactic acid, polyglycolic acid, a polyanhydride, polycaprolactone, polyhydroxybutyrate valerate, a biodegradable polymer, a protein, an extracellular matrix component, collagen, fibrin, a biologic agent, PEBAX, polyethylene, irradiated polyethylene, and copolymers, mixtures, analogs, derivatives and pharmaceutically acceptable salts thereof; and

wherein the second coating layer comprises a material selected from the group consisting of;

paclitaxel, rapamycin, methotrexate, cytochalasin, colchicine, cyclosporine, the protein product of the retinoblastoma tumor suppressor gene, angiopeptin, a vascular endothelial growth factor (VEGF), urokinase, streptokinase, heparin, hirudin, aspirin, ticlopidine, argatroban, D-phenylalanyl-L-poly-L-arginyl chloromethyl ketone, an omega 3-fatty acid, Lovastatin, nitric oxide, Estrogen, Dopamine, bromocriptine mesylate, pergolide mesylate, streptomycin, erythromycin, vancomycin, forskolin, vapiprost, prostaglandin, prostacyclin, Seramin, triazolopyrimidine, alpha interferon, Captopril®

, Cilazapril®

, Lisinopril®

, dexamethasone, ⁶⁰Co, ¹⁹²Ir, ³²P, ¹¹¹In, ⁹⁰Y, ⁹⁹mTc, an iodine-containing radiopaque compound, barium-containing radiopaque compound, gold, tantalum, platinum, tungsten, a ¹⁴C-radiolabelling compound, a ³H-radiolabelling compound, a ¹³¹I-radiolabelling compound, a ³²P-radiolabelling compound, a ³⁶S radiolabelling compound, ascorbic acid, alphatocopherol, superoxide dismutase, deferoxyamine, a 21-aminosteroid (lasaroid), dipyridamole, nitroprusside, a polyamide, polyethylene terephthalate, polyurethane, a polyester, a polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, polylactic acid, polyglycolic acid, a polyanhydride, polycaprolactone, polyhydroxybutyrate valerate, a biodegradable polymer, a protein, an extracellular matrix component, collagen, fibrin, a biologic agent, PEBAX, polyethylene, irradiated polyethylene, and copolymers, mixtures, analogs, derivatives and pharmaceutically acceptable salts thereof.