Coated medical device

• US 7,731,685 B2
• Filed: 09/23/2005
• Issued: 06/08/2010
• Est. Priority Date: 07/12/2002
• 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: Burton, David G., Schaeffer, Darin G., Boatman, Scott E., Sturgeon, Jason S., Bates, Brian L., Hoffa, Michael C., Ragheb, Anthony O.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Mehta; Bhisma
• Application Number:
  US11/234,702
• Publication Number:
  US 20060020331A1
• Time in Patent Office: 1,719 Days
• Field of Search: 604/96.01, 604/103.02, 604/103.06, 604/103.11, 604/264, 604/265, 604/266, 604/500, 604506-509
• US Class Current: 604/103.02
• 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 for delivering a bioactive material to a vessel wall of a patient comprising:

a balloon catheter having an expandable balloon attached to a catheter shaft, the balloon having an expandable outer surface formed from a base material;

a hydrophilic layer including a hydrophilic material posited on the outer surface; and

a bioactive layer including a total of about 5 micrograms to about 500 micrograms of a lipophilic bioactive material disposed on the hydrophilic layer over the outer surface and about 0.2 micrograms to about 20 micrograms of the lipophilic bioactive material per square mm of the expanded outer surface of the balloon;

the expandable balloon being free of any additional coating or layer atop the bioactive layer and

the hydrophilic layer being positioned between the expandable outer surface and the bioactive material, wherein the hydrophilic layer is chosen such that the adhesion of the bioactive material to the hydrophilic layer is less than the adhesion of the bioactive material to the base material and wherein the hydrophilic layer enhances delivery of the bioactive material to the vessel wall.

2. The implantable medical device of claim 1, wherein the lipophilic bioactive material is an anti-angiogenic agent.

5. The method of claim 1, wherein the bioactive material is selected from the group consisting of paclitaxel, paclitaxel analogs, paclitaxel derivatives and pharmaceutically acceptable salts thereof.

6. The method of claim 1, the balloon catheter further comprising a first coating layer posited on at least a portion of the expandable outer surface of the expandable balloon and a second coating layer posited on at least a portion of first coating layer, where the first coating layer comprises the hydrophilic layer and the second coating layer comprises the bioactive layer and the expandable balloon structure comprises a material selected from the group consisting of:

a polyamide, polyethylene terephthalate, polyurethane, a polyester, a polyorthoester, polyanhydride, polyethylene, irradiated polyethylene and or a mixture or copolymer thereof.

7. The method of claim 1, wherein the balloon catheter comprises a biocompatible polymeric material.

8. The method of claim 1, wherein the balloon catheter 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, polyethylene, irradiated polyethylene and or a mixture or copolymer thereof.

3. A method of delivering a bioactive material to an interior wall of a body vessel, the method comprising:

a. inserting a balloon catheter having an expandable balloon attached to a catheter shaft, the balloon having an expandable outer surface formed from a base material;

a hydrophilic layer including a hydrophilic material posited on the outer surface; and

a bioactive layer including about 0.2 micrograms to about 20 micrograms of a bioactive material per square mm of surface area of the outer surface disposed on the hydrophilic layer over the outer surface;

the expandable balloon being free of any additional coating or layer atop the bioactive layer and the hydrophilic layer being positioned between the expandable outer surface and the bioactive material, wherein the hydrophilic layer is chosen such that the adhesion of the bioactive material to the hydrophilic layer is less than the adhesion of the bioactive material to the base material and wherein the hydrophilic layer enhances delivery of the bioactive material to the vessel wall;

b. advancing the balloon within the body vessel to a treatment site within the body vessel;

c. inflating the balloon at the treatment site to contact the bioactive material with an inner wall of the body vessel;

d. maintaining the bioactive material on the outer surface of the inflated balloon in contact with the inner wall of the body vessel while the balloon is inflated to transfer at least a portion of the bioactive material to the inner wall of the body vessel;

e. deflating the balloon after contacting the bioactive material with the inner wall of the body vessel; and

f. removing the deflated balloon from the body vessel.

4. The method of claim 3, where the bioactive material is a lipophilic bioactive material selected from the group consisting of paclitaxel and dexamethasone;

the hydrophilic material being configured to lessen the adhesion of the bioactive material to the balloon surface.

9. The method of claim 3, 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.

10. The method of claim 3, 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, an angiotensin converting enzyme inhibitor, 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 ¹³¹1-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.

11. The method of claim 3, wherein the bioactive material is selected from the group consisting of rapamycin, rapamycin analogs, rapamycin derivatives and pharmaceutically acceptable salts thereof.

12. The method of claim 3, where the bioactive material is a taxane bioactive material.

13. The method of claim 3, wherein the balloon is inflated for a time of up to approximately one minute.

14. An implantable medical device for delivering a bioactive material to a vessel wall of a patient comprising:

a balloon catheter having an expandable balloon attached to a catheter shaft, the balloon having an expandable outer surface formed from a base material;

a hydrophilic layer including a hydrophilic material posited on the outer surface of the balloon; and

a bioactive layer disposed on the hydrophilic layer with the expandable balloon being free of any additional coating or layer atop the bioactive layer, the bioactive layer including a lipophilic bioactive material and disposed so as to expose amounts of the lipophilic bioactive material overlying the hydrophilic layer at an outermost surface over the balloon, the bioactive layer including a total of about 5 micrograms to about 500 micrograms of a lipophilic bioactive material and providing about 0.2 micrograms to about 20 micrograms of the lipophilic bioactive material per square mm of the expanded outer surface of the balloon; and

the hydrophilic layer being positioned between the expandable outer surface and the bioactive material

and configured to facilitate the detachment of the overlying amounts of the lipophilic bioactive material from the balloon catheter and delivery of the bioactive material to the vessel wall as compared to a corresponding balloon catheter having the bioactive material disposed directly on the surface of the balloon, wherein the hydrophilic layer is chosen such that the adhesion of the bioactive material to the hydrophilic layer is less than the adhesion of the bioactive material to the base material and wherein the hydrophilic layer enhances delivery of the bioactive material to the vessel wall.

15. A method of delivering a lipophilic bioactive material to an interior wall of a body vessel, the method comprising:

a. inserting a balloon catheter having an expandable balloon attached to a catheter shaft, the balloon having an expandable outer surface formed from a base material;

a hydrophilic layer including a hydrophilic material posited on the outer surface and between the outer surface and a bioactive layer;

the bioactive layer including a lipophilic bioactive material coated so as to present amounts of the lipophilic bioactive material overlying the hydrophilic layer at an outermost surface over the balloon catheter, the bioactive layer including about 0.2 micrograms to about 20 micrograms of the lipophilic bioactive material per square mm of surface area of the outer surface;

the expandable balloon being free of any additional coating or layer atop the bioactive layer and the hydrophilic layer being configured to lessen the adhesion of the overlying amounts of the bioactive material to the balloon catheter and facilitate delivery of the bioactive material to the vessel wall as compared to a corresponding balloon catheter having the bioactive material disposed directly on the surface of the balloon;

b. advancing the balloon within the body vessel to a treatment site within the body vessel;

c. inflating the balloon at the treatment site to directly contact the lipophilic bioactive material overlying the hydrophilic layer with an inner wall of the body vessel;

d. maintaining the bioactive material on the outer surface of the inflated balloon in contact with the inner wall of the body vessel while the balloon is inflated to transfer at least a portion of the bioactive material to the inner wall of the body vessel;

e. deflating the balloon after contacting the bioactive material with the inner wall of the body vessel; and

f. removing the deflated balloon from the body vessel.