Coated medical device

• US 20050278021A1
• Filed: 05/31/2005
• Published: 12/15/2005
• Est. Priority Date: 10/31/2000
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated)
• Inventors: Bates, Brian L., Fearnot, Neal E., Ragheb, Anthony O., Purdy, James D., Choules, Brian D., Bourdeau, William J., Stewart, Joseph M. IV
• Granted Patent: US 8,172,793 B2
• Time in Patent Office: Days
• US Class Current: 623/1.440
• 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 (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Claims

1. An implantable medical device comprising:

a structure adapted for implantation into a patient, the structure comprising a base material having at least one roughened surface; and

a bioactive deposited on the at least one roughened surface.

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

paclitaxel, a taxane, a paclitaxel analogue, estrogen, an estrogen derivative, heparin, hirudin, hirulog, argatroban, D-phenylalanyl-L-poly-L-arginyl chloromethyl ketone, urokinase, streptokinase, nitric oxide, aspirin, ticlopdine, vascular endothelial growth factor (VEGF), analogues of vascular endothelial growth factor (VEGF), colchicines, cytochalasin, the protein product of the retinoblastoma tumor suppressor gene, analogues of the retinoblastoma tumor suppressor gene, GP IIb/IIIa, GP Ib-IX, methotrexate, dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate, a dexamethasone derivative, prostaglandin, prostacyclin, analogues of prostaglandin or prostacylcin, cyclosporine, rapamycin, streptomycin, erythromycin, vancomycin, dopamine, bromocriptine mesylate, pergolide mesylate, a dopamine agonist, ⁶⁰Co, ¹⁹²Ir, ³²P, ¹¹¹In, ⁹⁰Y, ⁹⁹mTc, gold, tantalum, platinum, tungsten, captopril, enalapril, alphatocopherol, superoxide dismutase, deferoxyamine, a 21-aminosteroid (lasaroid), angiopeptin, a ¹⁴C-, ³H-, ¹³¹I-, ³²P- or ³⁶S-radio-labelled form or other radiolabelled form of any of the foregoing, or a mixture of any of these.

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

an antisense nucleotide, a thrombin inhibitor, an antithrombogenic agent, a tissue plasminogen activator, a thrombolytic agent, a fibrinolytic agent, a vasospasm inhibitor, a calcium channel blocker, a nitrate, a nitric oxide promoter, a vasodilator, an antimicrobial agent, an antibiotic, an antiplatelet agent, an antimitotic, a microtubule inhibitor, an actin inhibitor, a remodeling inhibitor, an agent for molecular genetic intervention, a cell cycle inhibitor, an inhibitor of the surface glycoprotein receptor, an antimetabolite, an antiproliferative agent, an anti-cancer chemotherapeutic agent, an anti-inflammatory steroid, an immunosuppressive agent, an antibiotic, a radiotherapeutic agent, iodine-containing compounds, barium-containing compounds, a heavy metal functioning as a radiopaque agent, a peptide, a protein, an enzyme, an extracellular matrix component, a cellular component, a biologic agent, an angiotensin converting enzyme (ACE) inhibitor, ascorbic acid, a free radical scavenger, an iron chelator, an antioxidant, a radiolabelled form or other radiolabelled form of any of the foregoing, or a mixture of any of these.

4. The implantable medical device of claim 1, wherein the at least one roughened surface is roughened with an abrasive particulate of between 5 and 500 microns.

5. The implantable medical device of claim 1, wherein between 5 and 500 micrograms of the bioactive paclitaxel is deposited on the at least one roughened surface.

6. The implantable medical device of claim 1, wherein the base material comprises one or more materials selected from the group consisting of:

stainless steel, tantalum, titanium, nitinol, gold, platinum, inconel, iridium, silver, tungsten, a biocompatible metal, carbon, carbon fiber, cellulose acetate, cellulose nitrate, silicone, polyethylene terephthalate, polyurethane, polyamide, polyester, polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, a biocompatible polymeric material, 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 or a suitable mixture, copolymer, or alloy of any of these.

7. The implantable medical device of claim 1, wherein the structure is a vascular stent.

8. The implantable medical device of claim 1, wherein the structure is self-expanding.

9. The implantable medical device of claim 1, further comprising a slip coating posited on the at least one surface of the base material, wherein the bioactive is posited on at least a portion of the slip coating.

10. The implantable medical device of claim 9, wherein the slip coating is hydrophilic and the bioactive is lipophilic.

11. The implantable medical device of claim 1, wherein the bioactive is paclitaxel and the base material is a biocompatible metal.

12. The implantable medical device of claim 1, wherein the bioactive is an antiproliferative agent.

13. The implantable medical device of claim 1, wherein the structure is a vascular stent comprising a base material comprising stainless steel comprising a roughened surface formed by abrading the surface with an abrasive particulate having a particle size of between about 5 micrometers and about 500 micrometers, and where the bioactive is paclitaxel.

14. An implantable medical device, comprising:

a structure adapted for implantation into a patient, the structure comprising a base material having at least one surface, wherein the base material is porous; and

a bioactive contained within the porous base material.

15. The implantable medical device of claim 14, wherein the bioactive is selected from the group consisting of:

paclitaxel, a taxane, a paclitaxel analogue, estrogen, an estrogen derivative, heparin, hirudin, hirulog, argatroban, D-phenylalanyl-L-poly-L-arginyl chloromethyl ketone, urokinase, streptokinase, nitric oxide, aspirin, ticlopdine, vascular endothelial growth factor (VEGF), analogues of vascular endothelial growth factor (VEGF), colchicines, cytochalasin, the protein product of the retinoblastoma tumor suppressor gene, analogues of the retinoblastoma tumor suppressor gene, GP IIb/IIIa, GP Ib-IX, methotrexate, dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate, a dexamethasone derivative, prostaglandin, prostacyclin, analogues of prostaglandin or prostacylcin, cyclosporine, rapamycin, streptomycin, erythromycin, vancomycin, dopamine, bromocriptine mesylate, pergolide mesylate, a dopamine agonist, ⁶⁰Co, ¹⁹²Ir, 32P, 111In, 90Y, 99mTc, gold, tantalum, platinum, tungsten, captopril, enalapril, alphatocopherol, superoxide dismutase, deferoxyamine, a 21-aminosteroid (lasaroid), angiopeptin, a ¹⁴C-, ³H-, ¹³¹I-, ³²P- or ³⁶S-radiolabelled form or other radiolabelled form of any of the foregoing, or a mixture of any of these.

16. The implantable medical device of claim 14, wherein the bioactive is selected from the group consisting of:

an antisense nucleotide, a thrombin inhibitor, an antithrombogenic agent, a tissue plasminogen activator, a thrombolytic agent, a fibrinolytic agent, a vasospasm inhibitor, a calcium channel blocker, a nitrate, a nitric oxide promoter, a vasodilator, an antimicrobial agent, an antibiotic, an antiplatelet agent, an antimitotic, a microtubule inhibitor, an actin inhibitor, a remodeling inhibitor, an agent for molecular genetic intervention, a cell cycle inhibitor, an inhibitor of the surface glycoprotein receptor, an antimetabolite, an antiproliferative agent, an anti-cancer chemotherapeutic agent, an anti-inflammatory steroid, an immunosuppressive agent, an antibiotic, a radiotherapeutic agent, iodine-containing compounds, barium-containing compounds, a heavy metal functioning as a radiopaque agent, a peptide, a protein, an enzyme, an extracellular matrix component, a cellular component, a biologic agent, an angiotensin converting enzyme (ACE) inhibitor, ascorbic acid, a free radical scavenger, an iron chelator, an antioxidant, a radiolabelled form or other radiolabelled form of any of the foregoing, or a mixture of any of these.

17. The implantable medical device of claim 14, wherein the bioactive is an immunosuppressive agent.

18. The implantable medical device of claim 14, wherein the bioactive is paclitaxel.

19. The implantable medical device of claim 14, wherein the base material comprises aluminum oxide.

20. A medical device comprising at least one surface comprising a base material, where at least a portion of the at least one surface is treated with 5 to 500-micrometer abrasive particles to produce a roughened or textured surface;

and a bioactive material is posited on the at least one roughened or textured surface.

21. The medical device of claim 20, where the bioactive is paclitaxel.

22. The medical device of claim 20, where positing the bioactive comprises the step of spraying a solution of the bioactive on the roughened or textured surface of the base material of the structure.