COATED MEDICAL DEVICE

• US 20110015725A1
• Filed: 09/28/2010
• Published: 01/20/2011
• Est. Priority Date: 07/12/2002
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Burton, David G., Boatman, Scott E., Sturgeon, Jason S., Bates, Brian L., Hoffa, Michael C., Ragheb, Anthony O., Schaeffer, Darin G.
• Granted Patent: US 10,532,190 B2
• Time in Patent Office: Days
• US Class Current: 623/1.46
• 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. A coated endoluminal medical device comprising:

an expandable structure having an expanded condition and a layer of base material having an outer surface, and

a layer of bioactive material sprayed, posited or disposed on the outer surface of the base material while the expandable structure was in the expanded condition.

2. The coated endoluminal medical device according to claim 1, wherein the bioactive material is a lipophilic material.

3. The coated endoluminal medical device according to claim 1, further comprising a hydrophilic material layer posited on and between the base material layer and the bioactive material layer.

4. The coated endoluminal medical device according to claim 1, wherein the expandable structure includes an inflatable balloon.

5. The coated endoluminal medical device according to claim 4, wherein the expandable structure includes an expandable stent positioned around the inflatable balloon.

6. The coated endoluminal medical device according to claim 5, further comprising a lipophilic material layer on said balloon extending beyond ends of the stent disposed around said balloon.

14. The medical device according to claim 1, wherein the layer of base material of the structure comprises at least one of:

stainless steel, tantalum, titanium, nitinol, gold, platinum, inconel, iridium, silver, tungsten, or another biocompatible metal, or alloys of any of these;

carbon or carbon fiber;

cellulose acetate, cellulose nitrate, silicone, polyethylene terephthalate, polyurethane, polyamide, polyester, polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, or another biocompatible polymeric material, or mixtures or copolymers of these;

polylactic acid, polyglycolic acid or copolymers thereof, a polyanhydride, polycaprolactone, polyhydroxybutyrate valerate or another biodegradable polymer, or mixtures or copolymers of these;

a protein, an extracellular matrix component, collagen, fibrin or another biologic agent;

or a suitable mixture of any of these.

17. The coated medical device according to claim 1, wherein the layer of bioactive material comprises at least one of:

paclitaxel, a taxane or other paclitaxel analogue;

estrogen or estrogen derivatives;

heparin or another thrombin inhibitor, hirudin, hirulog, argatroban, D-phenylalanyl-L-poly-L-arginyl chloromethyl ketone, or another antithrombogenic agent, or mixtures thereof;

urokinase, streptokinase, a tissue plasminogen activator, or another thrombolytic agent, or mixtures thereof;

a fibrinolytic agent;

a vasospasm inhibitor;

a calcium channel blocker, a nitrate, nitric oxide, a nitric oxide promoter or another vasodilator;

an antimicrobial agent or antibiotic;

aspirin, ticlopidine or another antiplatelet agent;

vascular endothelial growth factor (VEGF) or analogues thereof;

colchicine or another antimitotic, or another microtubule inhibitor;

cytochalasin or another actin inhibitor;

a remodeling inhibitor;

deoxyribonucleic acid, an antisense nucleotide or another agent for molecular genetic intervention;

a cell cycle inhibitor (such as the protein product of the retinoblastoma tumor suppressor gene, or analogues thereof GP IIb/IIIa, GP Ib-IX or another inhibitor or surface glycoprotein receptor;

methotrexate or another antimetabolite or antiproliferative agent;

an anti-cancer chemotherapeutic agent;

dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate or another dexamethasone derivative, or another anti-inflammatory steroid;

prostaglandin, prostacyclin or analogues thereof;

an immunosuppressive agent (such as cyclosporine or rapamycin);

an antibiotic (such as streptomycin), erythromycin orvancomycin;

dopamine, bromocriptine mesylate, pergolide mesylate or another dopamine agonist;

⁶⁰CO, ¹⁹²Ir, ³²P, ¹¹¹In, ⁹⁰Y, ^99mTc or another radiotherapeutic agent;

iodine-containing compounds, barium-containing compounds, gold, tantalum, platinum, tungsten or another heavy metal functioning as a radiopaque agent;

a peptide, a protein, an enzyme, an extracellular matrix component, a cellular component or another biologic agent;

captopril, enalapril or another angiotensin converting enzyme (ACE) inhibitor;

ascorbic acid, alphatocopherol, superoxide dismutase, deferoxyamine, a 21-aminosteroid (lasaroid) or another free radical scavenger, iron chelator or antioxidant;

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.

7. A coated endoluminal medical device comprising:

a layer of base material having at least one of a roughened, uneven, unsmooth or textured outer surface, and

a layer of bioactive material sprayed, posited, or disposed on the outer surface of the base material.

8. The coated medical device according to claim 7, wherein the bioactive material is a lipophilic material.

9. The coated medical device according to claim 7, further comprising a hydrophilic material layer posited on and between the base material layer and the bioactive material layer.

15. The medical device according to claim 7, wherein the layer of base material comprises at least one of:

stainless steel, tantalum, titanium, nitinol, gold, platinum, inconel, iridium, silver, tungsten, or another biocompatible metal, or alloys of any of these;

carbon or carbon fiber;

cellulose acetate, cellulose nitrate, silicone, polyethylene terephthalate, polyurethane, polyamide, polyester, polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, or another biocompatible polymeric material, or mixtures or copolymers of these;

polylactic acid, polyglycolic acid or copolymers thereof, a polyanhydride, polycaprolactone, polyhydroxybutyrate valerate or another biodegradable polymer, or mixtures or copolymers of these;

a protein, an extracellular matrix component, collagen, fibrin or another biologic agent;

or a suitable mixture of any of these.

18. The coated medical device according to claim 7, wherein the layer of bioactive material comprises at least one of:

paclitaxel, a taxane or other paclitaxel analogue;

estrogen or estrogen derivatives;

heparin or another thrombin inhibitor, hirudin, hirulog, argatroban, D-phenylalanyl-L-poly-L-arginyl chloromethyl ketone, or another antithrombogenic agent, or mixtures thereof;

urokinase, streptokinase, a tissue plasminogen activator, or another thrombolytic agent, or mixtures thereof;

a fibrinolytic agent;

a vasospasm inhibitor;

a calcium channel blocker, a nitrate, nitric oxide, a nitric oxide promoter or another vasodilator;

an antimicrobial agent or antibiotic;

aspirin, ticlopidine or another antiplatelet agent;

vascular endothelial growth factor (VEGF) or analogues thereof;

colchicine or another antimitotic, or another microtubule inhibitor;

cytochalasin or another actin inhibitor;

a remodeling inhibitor;

deoxyribonucleic acid, an antisense nucleotide or another agent for molecular genetic intervention;

a cell cycle inhibitor (such as the protein product of the retinoblastoma tumor suppressor gene, or analogues thereof);

GP IIb/IIIa, GP Ib-IX or another inhibitor or surface glycoprotein receptor;

methotrexate or another antimetabolite or antiproliferative agent;

an anti-cancer chemotherapeutic agent;

dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate or another dexamethasone derivative, or another anti-inflammatory steroid;

prostaglandin, prostacyclin or analogues thereof;

an immunosuppressive agent (such as cyclosporine or rapamycin);

an antibiotic (such as streptomycin), erythromycin or vancomycin;

dopamine, bromocriptine mesylate, pergolide mesylate or another dopamine agonist;

⁶⁰Co, ¹⁹²Ir, ³²P, ¹¹¹In, ⁹⁰Y, ^99mTc or another radiotherapeutic agent;

iodine-containing compounds, barium-containing compounds, gold, tantalum, platinum, tungsten or another heavy metal functioning as a radiopaque agent;

a peptide, a protein, an enzyme, an extracellular matrix component, a cellular component or another biologic agent;

captopril, enalapril or another angiotensin converting enzyme (ACE) inhibitor;

ascorbic acid, alphatocopherol, superoxide dismutase, deferoxyamine, a 21-aminosteroid (lasaroid) or another free radical scavenger, iron chelator or antioxidant;

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.

10. A coated medical device comprising:

an inflatable balloon having a base material layer, and a bioactive material layer posited on said base material layer.

11. The coated material medical device according to claim 10, further comprising an implantable stent including a base material layer and a bioactive material layer posited thereon, wherein said stent is disposed around said balloon.

12. The coated medical device according to claim 10, wherein the bioactive material layer posited on the stent and the balloon comprises a lipophilic bioactive material layer.

13. The coated medical device according to claim 10, wherein the bioactive material layer on said balloon comprises a lipophilic material layer and extends beyond the ends of the stent disposed around said balloon.

16. The medical device according to claim 10, wherein the base material layer comprises at least one of:

stainless steel, tantalum, titanium, nitinol, gold, platinum, inconel, iridium, silver, tungsten, or another biocompatible metal, or alloys of any of these;

carbon or carbon fiber;

cellulose acetate, cellulose nitrate, silicone, polyethylene terephthalate, polyurethane, polyamide, polyester, polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, or another biocompatible polymeric material, or mixtures or copolymers of these;

polylactic acid, polyglycolic acid or copolymers thereof, a polyanhydride, polycaprolactone, polyhydroxybutyrate valerate or another biodegradable polymer, or mixtures or copolymers of these;

a protein, an extracellular matrix component, collagen, fibrin or another biologic agent;

or a suitable mixture of any of these.

19. The coated medical device according to claim 10, wherein the bioactive material layer comprises at least one of:

paclitaxel, a taxane or other paclitaxel analogue;

estrogen or estrogen derivatives;

heparin or another thrombin inhibitor, hirudin, hirulog, argatroban, D-phenylalanyl-L-poly-L-arginyl chloromethyl ketone, or another antithrombogenic agent, or mixtures thereof;

urokinase, streptokinase, a tissue plasminogen activator, or another thrombolytic agent, or mixtures thereof;

a fibrinolytic agent;

a vasospasm inhibitor;

a calcium channel blocker, a nitrate, nitric oxide, a nitric oxide promoter or another vasodilator;

an antimicrobial agent or antibiotic;

aspirin, ticlopdine or another antiplatelet agent;

vascular endothelial growth factor (VEGF) or analogues thereof;

colchicine or another antimitotic, or another microtubule inhibitor;

cytochalasin or another actin inhibitor;

a remodeling inhibitor;

deoxyribonucleic acid, an antisense nucleotide or another agent for molecular genetic intervention;

a cell cycle inhibitor (such as the protein product of the retinoblastoma tumor suppressor gene, or analogues thereof);

GP IIb/IIIa, GP Ib-IX or another inhibitor or surface glycoprotein receptor;

methotrexate or another antimetabolite or antiproliferative agent;

an anti-cancer chemotherapeutic agent;

dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate or another dexamethasone derivative, or another anti-inflammatory steroid;

prostaglandin, prostacyclin or analogues thereof;

an immunosuppressive agent (such as cyclosporine or rapamycin);

an antibiotic (such as streptomycin), erythromycin or vancomycin;

dopamine, bromocriptine mesylate, pergolide mesylate or another dopamine agonist;

⁶⁰CO, ¹⁹²Ir, ³²P, ¹¹¹In, ⁹⁰Y, ^99mTc or another radiotherapeutic agent;

iodine-containing compounds, barium-containing compounds, gold, tantalum, platinum, tungsten or another heavy metal functioning as a radiopaque agent;

a peptide, a protein, an enzyme, an extracellular matrix component, a cellular component or another biologic agent;

captopril, enalapril or another angiotensin converting enzyme (ACE) inhibitor;

ascorbic acid, alphatocopherol, superoxide dismutase, deferoxyamine, a 21-aminosteroid (lasaroid) or another free radical scavenger, iron chelator or antioxidant;

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.

20. The coated medical device of claim 10, wherein said base material comprises at least one of a group consisting of polyamid, polyethylene, PEBAX or irradiated polyethylene.