CA2178541A1 - Implantable medical device - Google Patents

Implantable medical device

Info

Publication number
CA2178541A1
CA2178541A1 CA002178541A CA2178541A CA2178541A1 CA 2178541 A1 CA2178541 A1 CA 2178541A1 CA 002178541 A CA002178541 A CA 002178541A CA 2178541 A CA2178541 A CA 2178541A CA 2178541 A1 CA2178541 A1 CA 2178541A1
Authority
CA
Canada
Prior art keywords
another
bioactive material
bioactive
layer
agent
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002178541A
Other languages
French (fr)
Other versions
CA2178541C (en
Inventor
Neal E. Fearnot
Thomas G. Kozma
Anthony O. Ragheb
William D. Voorhees, Iii
Brian L. Bates
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cook Inc
Cook Research Inc
Original Assignee
Cook Inc
MED Institute Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US08/484,532 external-priority patent/US5609629A/en
Application filed by Cook Inc, MED Institute Inc filed Critical Cook Inc
Publication of CA2178541A1 publication Critical patent/CA2178541A1/en
Application granted granted Critical
Publication of CA2178541C publication Critical patent/CA2178541C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/12—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules
    • A61K51/1282—Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A61L29/085—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A61L29/10—Inorganic materials
    • A61L29/106—Inorganic materials other than carbon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/082—Inorganic materials
    • A61L31/088—Other specific inorganic materials not covered by A61L31/084 or A61L31/086
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/146—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L33/00—Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
    • A61L33/02—Use of inorganic materials
    • A61L33/022—Metal or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602—Type of release, e.g. controlled, sustained, slow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606—Coatings
    • A61L2300/608—Coatings having two or more layers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/08—Coatings comprising two or more layers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1002—Intraluminal radiation therapy

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 layer 18 of a bioactive material posited on one surface of structure 12; and at least one porous layer 20 posited over the bioactive material layer 18 posited on one surface of structure (12) and the bioactive-material-free surface. Preferably, the structure 12 is a coronary stent. The porous layer 20 is comprised of a polymer applied preferably by vapor or plasma deposition and provides 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, merely by condensation of a monomer vapor. The invention is also directed to the method of manufacture of the device 10, as well as a method of using it in medical treatments.

Claims (111)

1. An implantable medical device (10), comprising:
a structure (12) adapted for introduction into a patient, the structure (12) being composed of a base material (14);
at least one layer (18) of a bioactive material posited on one surface of the structure (12); and at least one porous layer (20) posited over the bioactive material layer (18), composed of a polymer and being of a thickness adequate to provide a controlled release of the bioactive material.
2. The device (10) according to claim 1, wherein the at least one porous layer (20) is one polymerized from a catalyst-free monomer vapor.
3. The device (10) according to claim 1, wherein the polymer is selected from the group consisting essentially of a polyamide, polymers of parylene or derivatives thereof, poly(ethylene oxide), poly(ethylene glycol), poly(propylene oxide), silicone based polymers, polymers of methane, tetrafluoroethylene or tetramethyldisiloxane or a polymer derived from photopolymerizeable monomers.
4. The device (10) according to claim 3, wherein the thickness of the at least one porous layer (20) is about 5,000 to 250,000 .ANG..
5. The device (10) according to claim 1, further comprising at least one additional coating layer (16) between the structure (12) and the at least one bioactive material layer (18).
6. The device (10) according to claim 5, wherein the at least one additional coating layer (16) is less porous than, but composed of the same or different polymer as, the at least one porous layer (20).
7. The device (10) according to claim 6, wherein the polymer is selected from the group consisting essentially of polyamide, polymers of parylene or derivatives thereof, or a polymer derived from photopolymerizable monomers of bisphenol A diglycidyl ether and acrylic acid or methacrylic acid, and the at least one additional coating layer (16) is about 50,000 to 500,000 .ANG. thick.
8. The device (10) according to claim 1, wherein the structure (12) is configured as a vascular stent.
9. The device (10) according to claim 1, wherein the structure (12) is configured as at least one of: a stent, a vascular or other graft, a vascular or other graft in combination with a stent, heart valve, an orthopedic device, appliance, implant or replacement, or portion thereof; or a portion of any of these.
10. The device (10) according to claim 1, wherein the base material (14) is biocompatible.
11. The device (10) according to claim 10, wherein the base material (14) of the structure (12) includes 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 teraphthalate, polyurethane, polyamide, polyester, polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, or another biocompatible polymeric material, or mixtures or copolymers thereof; polylactic acid, polyglycolic acid or copolymers thereof, a polyanhydride, polycaprolactone, polyhydroxy-butyrate 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 mixture thereof.
12. The device (10) according to claim 1, wherein the bioactive material includes at least one of: heparin, covalent 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, a glycoprotein IIb/IIIa inhibitor or another inhibitor of surface glycoprotein receptors, or another antiplatelet agent; colchicine or another antimitotic, or another microtubule inhibitor, dimethyl sulfoxide (DMSO), a retinoid or another antisecretory agent;
cytochalasin or another actin inhibitor; or a remodeling inhibitor; deoxyribonucleic acid, an antisense nucleotide or another agent for molecular genetic intervention; methotrexate or another antimetabolite or antiproliferative agent; tamoxifen citrate, Taxol? or derivatives thereof, or other anti-cancer chemotherapeutic agents; dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate or another dexamethasone derivative, or another anti-inflammatory steroid or non-steroidal anti-inflammatory agent; cyclosporin or another immunosuppressive agent; trapidal (a PDGF antagonist), angiogenin, angiopeptin (a growth hormone antagonist), a growth factor or an anti-growth factor antibody, or another growth factor antagonist; dopamine, bromocriptine mesylate, pergolide mesylate or another dopamine agonist; 60Co 192Ir 32p 11lIn, soY, 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, alpha tocopherol, superoxide dismutase, deferoxamine, a 21-amino steroid (lasaroid) or another free radical scavenger, iron chelator or antioxidant; a 14C-, 3H-, 131I-, 32p- or 36S-radiolabelled form or other radiolabelled form of any of the foregoing; estrogen or another sex hormone; AZT or other antipolymerases; acyclovir, famciclovir, rimantadine hydrochloride, ganciclovir sodium or other antiviral agents; 5-aminolevulinic acid, meta-tetrahydroxyphenylchlorin, hexadecafluoro zinc phthalocyanine, tetramethyl hematoporphyrin, rhodamine 123 or other 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 or other antibody targeted therapy agents; gene therapy agents; and enalapril and other prodrugs, or a mixture of any of these.
13. The device (10) according to claim 1, wherein the at least one layer (18) of bioactive material contains about 0.01 to 4 mg of the bioactive material per cm2 of the gross surface area of the structure (12).
14. The device (10) according to claim 1, wherein different bioactive materials are posited on the different surfaces of the structure (12).
15. The device (10) according to claim 1 wherein a bioactive material is posited on one surface of structure (12), a porous layer (20) is posited over the bioactive material (18) on the one surface of structure (12) and over the bioactive-material-free surface of structure (12), and a second bioactive material is posited on porous layer (20) and forms the outermost layer for structure (12).
16. The device according to claim 15 wherein a different and third bioactive material is posited on the bioactive-material-free side of structure (12) and further having porous layer (20) posited over the first and third bioactive materials; and wherein the second bioactive material forming the outermost layer is covalent heparin bound to porous layer (20).
17. The device according to claim 1 wherein the structure (12) comprises either a single bioactive material on one surface of said structure (12) or different bioactive materials on the different surfaces of structure (12) with a porous layer (20) over said bioactive material or materials and said second bioactive material forms the outermost layer over porous layer (12).
18. The device (10) according to claim 1 wherein plural but different bioactive materials are posited on the different surfaces of structure (12) with the proviso that the same bioactive material is not posited on the different surfaces of the structure (12) within the same layer and that the outermost layer may comprise either a porous layer or a bioactive material layer.
19. The device (10) according to claim 1 wherein said bioactive material (18) is posited on said one surface of structure (12) in a geometric pattern.
20. The device (10) according to claim 19 wherein said device is a stent and said bioactive material (18) is posited on one surface of the stent in a discontinuous geometric pattern.
21. The device (10) according to claim 20 wherein bioactive material (18) is posited on one surface of the stent in a pattern of parallel lines or wherein the bioactive material is not posited on the tips of the stent.
22. The device according to claim 1 wherein two or more different bioactive materials (18) are posited on one surface of the structure (12).
23. The device (10) according to claim 22 wherein the two or more bioactive materials (18) are posited on adjacent areas of the one surface of structure (12).
24. The device (10) according to claim 1, further comprising a connector (26) securing the at least one porous layer (20) to the base material (14) of the structure (12).
25. An implantable vascular device, comprising:
A. a stent structure adapted for introduction into a vascular system of a patient, the stent structure comprising a biocompatible metal;

B. at least one bioactive material posited on one surface of the structure of the stent; and C. a porous layer posited over the bioactive material and the bioactive-material-free stent surface, wherein said porous layer being at least about 5000 .ANG. thick adequate to provide a controlled release of the bioactive material.
26. The device according to claim 25 wherein the stent surface is coated with a substantially non-porous coating layer have a thickness of about 50,000 .ANG. to about 500,000 .ANG. wherein the coating layer comprises a polymer selected from the group consisting essentially of polyamide, a polymer derived from parylene or derivatives thereof, polyalkylene oxides, polyalkylene glycols, silicon based polymers, polymers derived from methane, tetrafluoro-ethylene, tetramethyldisiloxane, or polymers derived from photopolymerizeable monomers or mixtures of such polymers or copolymers thereof.
27. The device (10) according to claim 25, wherein the bioactive material includes at least one of: heparin, covalent 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, a glycoprotein IIb/IIIa inhibitor or another inhibitor of surface glycoprotein receptors, or another antiplatelet agent; colchicine or another antimitotic, or another microtubule inhibitor, dimethyl sulfoxide (DMSO), a retinoid or another antisecretory agent;
cytochalasin or another actin inhibitor; or a remodeling inhibitor; deoxyribonucleic acid, an antisense nucleotide or another agent for molecular genetic intervention; methotrexate or another antimetabolite or antiproliferative agent; tamoxifen citrate, Taxol? or derivatives thereof, or other anti-cancer chemotherapeutic agents; dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate or another dexamethasone derivative, or another anti-inflammatory steroid or non-steroidal anti-inflammatory agent; cyclosporin or another immunosuppressive agent; trapidal (a PDGF antagonist), angiopeptin (a growth hormone antagonist), angiogenin, or other growth factors, or an anti-growth factor antibody, or another growth factor antagonist;
dopamine, bromocriptine mesylate, pergolide mesylate or another dopamine agonist; 60Co, 192Ir 3?, 111In, ?, 9?c 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, alpha tocopherol, superoxide dismutase, deferoxamine, a 21-amino steroid (lasaroid) or another free radical scavenger, iron chelator or antioxidant; a 14C-, 3H-, 131I-, 32P- or 36S-radiolabelled form or other radiolabelled form of any of the foregoing; estrogen or another sex hormone; AZT or other antipolymerases; acyclovir, famciclovir, rimantadine hydrochloride, ganciclovir sodium or other antiviral agents;
5-aminolevulinic acid, meta-tetrahydroxyphenylchlorin, hexadecafluoro zinc phthalocyanine, tetramethyl hematoporphyrin, rhodamine 123 or other 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 or other antibody targeted therapy agents; enalapril or other prodrugs; gene therapy agents, or a mixture of any of these;
and various forms of small intestine submucosa (SIS).
28. The device (10) according to claim 25, wherein the at least one layer (18) of bioactive material contains about 1 to 4 mg of the bioactive material per cm2 of the gross surface area of the structure (12).
29. The device according to claim 25, wherein different bioactive materials are posited on the different surfaces of the stent structure.
30. The device according to claim 25 wherein a bioactive material (18) is posited on one surface of the stent structure (12), a porous layer (20) is posited over the bioactive material (18) on the one surface of the stent structure (12) and over the bioactive-material-free surface of the stent structure (12), and a second bioactive material (18) is posited on the porous layer (20) and forms the outermost layer for the stent structure (12).
31. The device according to claim 30 wherein a different and third bioactive material (18) is posited on the bioactive-material-free surface of the stent structure (12) further having a porous layer (20) posited over the bioactive materials (18) and wherein the second bioactive material (18) forming the outermost layer is covalent heparin bound to the porous layer.
32. The device according to claim 25 wherein the stent structure comprises either a single bioactive material on one surface of said structure (12) or different bioactive materials (18) on the different surfaces of the stent structure (12) with a porous layer over said bioactive material (18) or materials (18) and said second bioactive material forms the outermost layer over the porous layer.
33. The device according to claim 25 wherein multiple layers comprise the stent surfaces wherein such layers comprise alternating porous layers and at least one bioactive material layer and wherein different bioactive materials are posited on the different surfaces of the stent structure with the proviso that the same bioactive material is not posited on the different surfaces of the stent structure within the same layer and that a porous layer is posited over each bioactive material layer and the outermost layer may comprise either a porous layer or a bioactive material layer.
34. The device according to claim 25 wherein said bioactive material (18) is posited on said one surface of stent structure (12) in a geometric pattern.
35. The device according to claim 34 wherein the bioactive material (18) is posited on one surface of the stent structure (12) in a pattern of parallel lines or a pattern wherein the bioactive material is not posited on the tips of the stent.
36. The device according to claim 25 wherein two or more different bioactive materials (18) are posited on one surface of the stent structure (12).
37. The device according to claim 36 wherein the two or more bioactive materials (18) are posited on adjacent areas of the one surface of the stent structure (12).
38. A method of medically treating a patient by the step of inserting an implantable medical device (10) into the patient, the device (10) comprising a structure (12) adapted for introduction into the patient, and the structure (12) being composed of a base material (14), the method comprising the preliminary steps of:
depositing at least one layer (18) of a bioactive material on one surface of the structure (12); and depositing at least one porous layer (20) over the at least one bioactive material layer (18) and the bioactive-material-free surface of structure (12), the at least one porous layer being composed of a polymer and having a thickness adequate to provide a controlled release of the bioactive material.
39. The method according to claim 38, wherein the at least one porous layer (20) is deposited on the one surface of structure (12) by polymerizing the at least one layer (20) from a catalyst-free monomer vapor.
40. The method according to claim 38, wherein at least one porous layer (20) comprise a polymer selected from the group consisting essentially of polyamide, polymers of parylene, or derivative thereof, poly(ethylene oxide), poly(ethylene glycol), poly(propylene oxide), silicone based polymers, polymers of methane, tetrafluoroethylene or tetramethyldisiloxane or polymers of photopolymerizable monomers.
41. The method according to claim 40 wherein the at least one porous layer (20) is applied to thickness of about 5,000 to 250,000 .ANG..
42. The method according to claim 38, comprising the further step of depositing at least one additional coating layer (16) between the structure (12) and the at least one bioactive material layer (18).
43. The method according to claim 42, wherein the step of depositing the at least one additional coating layer (16) is carried out so that the at least one additional coating layer (16) is less porous than, but composed of the same or different polymer as, the at least one porous layer (20).
44. The method according to claim 43, wherein the at least one additional coating layer (16) comprises a polymer selected from the group consisting essentially of polyimides, polymers derived from parylene or a parylene derivative, and the at least one coating layer (16) is applied to a thickness of about 50,000 to 500,000 .ANG..
45. The method according to claim 38, wherein the method is carried out with a structure (12) configured as a vascular stent, and wherein the method comprises the step of inserting the vascular stent into the vascular system of the patient, subsequent to the deposition of the different layers.
46. The method according to claim 26, wherein the method is carried out with a base material (14) which is biocompatible.
47. The method according to claim 46, wherein the method is carried out with a structure (12) whose base material (14) includes 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 teraphthalate, 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, polyhydroxy-butyrate 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 mixture of any of these.
48. The method according to claim 26, wherein the step of depositing the at least one bioactive material layer (18) is carried out with a bioactive material which includes at least one of: heparin, covalent 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, a glycoprotein IIb/IIIa inhibitor or another inhibitor of surface glycoprotein receptors, or another antiplatelet agent; colchicine or another antimitotic, or another microtubule inhibitor, dimethyl sulfoxide (DMSO), a retinoid or another antisecretory agent; cytochalasin or another actin inhibitor; or a remodeling inhibitor; deoxyribonucleic acid, an antisense nucleotide or another agent for molecular genetic intervention; GP Iib/IIIa, GP Ib-IX or another inhibitor or surface glycoprotein receptor; methotrexate or another antimetabolite or antiproliferative agent; tamoxifen citrate, Taxol? or derivatives thereof, or other anti-cancer chemotherapeutic agents; dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate or another dexamethasone derivative, or another anti-inflammatory steroid or non-steroidal anti-inflammatory agent; cyclosporin or another immunosuppressive agent; trapidal (a PDGF antagonist), angiopeptin (a growth hormone antagonist), angiogenin, a growth factor or an anti-growth factor antibody, or another growth factor antagonist; 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, alpha tocopherol, superoxide dismutase, deferoxamine, a 21-amino steroid (lasaroid) or another free radical scavenger, iron chelator or antioxidant; a 14C-, 3H-, 131I-, 32P- or 36S-radiolabelled form or other radiolabelled form of any of the foregoing; estrogen or another sex hormone; AZT or other antipolymerases; acyclovir, famciclovir, rimantadine hydrochloride, ganciclovir sodium or other antiviral agents; 5-aminolevulinic acid, meta-tetrahydroxyphenylchlorin, hexadecafluoro zinc phthalocyanine, tetramethyl hematoporphyrin, rhodamine 123 or other 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 or other antibody target therapy agents; enalapril or other prodrugs; gene therapy agents, or a mixture of any of these;
and various forms of small intestine submucosa (SIS).
49. The method according to claim 38, wherein the step of depositing the at least one layer (18) of bioactive material is carried out so that the at least one layer (18) contains about 1 to 4 mg of the bioactive material per cm2 of the gross surface area of the structure (12).
50. The method according to claim 38, wherein different bioactive materials are deposited on the different surfaces of the structure (12).
51. The method according to claim 38 wherein a bioactive material is deposited on one surface of structure (12), a porous layer (20) is posited over the bioactive material (18) on one surface of structure (12) and over the bioactive-material-free surface of structure (12), and a second bioactive material is posited on porous layer (20) and forms the outermost layer for structure (12).
52. The method according to claim 51 wherein a different and third bioactive material is deposited on the bioactive-material-free side of structure (12) further having porous layer (20) deposited over the different bioactive materials and wherein the second bioactive material forming the outermost layer is covalent heparin bound to porous layer (20).
53. The method according to claim 38 wherein the structure 12 comprises either a single bioactive material on one side of said structure (12) or different bioactive materials on the different sides of structure (12) with a porous layer (20) over said bioactive material or materials and said second bioactive material forms the outermost layer over porous layer (12).
54. The method according to claim 38 wherein multiple layers comprise the stent surfaces wherein such layers comprise alternating porous layers and at least one bioactive material and wherein different bioactive materials are posited on the different surfaces of structure (12) with the proviso that the same bioactive material is not posited on both surfaces of the structure (12) within the same layer and that the outermost layer may comprise either a porous layer or a bioactive material.
55. The method according to claim 38 wherein said bioactive material is deposited on one surface of structure (12) in a geometric pattern.
56. The method according to claim 55 wherein said device is a stent and said bioactive material (18) is deposited on one surface of the stent is a discontinuous geometric pattern.
57. The method according to claim 56 wherein bioactive material (18) is deposited on one surface of the stent in a pattern of parallel lines or a pattern wherein the bioactive material is not posited on the tips [arms?] of the stent.
58. The method according to claim 38 wherein two or more different bioactive materials (18) are deposited on one side of the structure (12).
59. The method according to claim 58 wherein the two or more bioactive materials (18) are deposited on adjacent areas of the one surface of structure (12).
60. The method according to claim 38, wherein the method is carried out with a device (10) further comprising a connector (26) securing the at least one porous layer (20) to the base material (14) of the structure (12).
61. A method of making an implantable medical device (10), the device (10) including a structure (12) adapted for introduction into a patient, and the structure (12) being composed of a base material (14); wherein the method comprises the steps of:
A. depositing at least one layer (18) of a bioactive material on one surface the structure (12); and B. depositing at least one porous layer (20) over the at least one bioactive material layer (18) and the bioactive-material-free surface of structure (12), the at least one porous layer (20) being composed of a polymer and being of a thickness adequate to provide a controlled release of the bioactive material.
62. The method according to claim 61, wherein the step of depositing the at least one porous layer (20) comprises polymerizing the at least one layer (20) from a catalyst-free monomer vapor.
63. The method according to claim 61, wherein the at least one porous layer (20) comprises a polymer selected from the group consisting essentially of polyimides, polymers derived from parylene or derivatives thereof, poly(ethylene oxide), poly(ethylene glycol), poly(propylene oxide), silicone based polymer, polymers of methane, tetrafluoroethylene or tetramethyldisiloxane or polymers derived from photopolymerizeable monomers.
64. The method according to claim 61 wherein the bioactive material (18) layer is deposited by a process selected from the group consisting essentially of adsorption, absorption, vapor phase deposition, plasma deposition, chemically binding to the surface of the device, utilizing surfactants as an adhesion medium, electrode position, or combinations thereof.
65. The method according to claim 64 wherein the bioactive material (18) layer is applied by vapor phase deposition, plasma deposition or by chemically binding to the substrate structure (12) and the bioactive material (18) is in the form of a powder, microencapsulated particles or a matrix incorporated material.
66. The method according to claim 61 wherein different bioactive materials are deposited on the different surfaces of the structure (12).
67. The method according to claim 61 wherein a first bioactive material is deposited on one surface of structure (12), a porous layer (20) is deposited over the bioactive material on one surface of the structure (12) and over the bioactive-material-free surface of structure 12 and a second bioactive material is deposited on the porous layer (20) and forms the outermost layer for structure (12).
68. The method according to claim 67 wherein a different and third bioactive material is deposited on the bioactive-material-free surface of structure (12) prior to the deposition of the porous layer (20) and the subsequent deposition of the second bioactive material on porous layer (20) forming the outermost layer for structure (12).
69. The method according to claim 61 wherein multiple layers are deposited on the surfaces of structure (12) wherein such layers comprise alternating porous layers and at least one bioactive material and wherein different bioactive materials are deposited on the different surfaces of structure (12) with the proviso that the same bioactive material is not deposited on both surfaces of structure (12) within the same layer and that a porous layer is deposited over each bioactive material layer wherein the outermost layer of structure (12) may comprise either a porous layer or a bioactive material layer.
70. The method according to claim 61 wherein the bioactive material (18) is deposited on one surface of structure (12) in a geometric pattern.
71. The method according to claim 70 wherein the device is a stent and the bioactive material (18) is deposited on one surface of the stent in a discontinuous geometric pattern.
72. The method according to claim 71 wherein the bioactive material (18) is deposited on one surface of the stent in a pattern of parallel lines or in a pattern wherein the bioactive material is not deposited on the tips of the stent.
73. The method according to claim 61 wherein two or more bioactive materials are deposited on one side or surface of the structure (12).
74. The method according to claim 73 wherein the two or more bioactive materials are deposited on adjacent areas of the one surface of structure (12).
75. The method according to claim 61, wherein the at least one porous layer (20) is applied to thickness of about 5,000 to 250,000 .ANG..
76. The method according to claim 61, wherein at least one porous layer (20) is carried out by sublimating and cracking di-p-xylylene or a derivative thereof to yield monomeric p-xylylene or a derivative thereof, and allowing the monomer so formed to simultaneously condense and polymerize over the bioactive material layer (18).
77. The method according to claim 76, wherein the sublimating and cracking step is carried out with dichloro-di-p-xylylene.
78. The method according to claim 61, wherein the step of depositing the at least one porous layer (20) is carried out in the absence of a solvent or catalyst for the polymer.
79. The method according to claim 61, wherein the step of depositing the at least one layer (18) of a bioactive material is carried out by applying over the structure (12) a mixture of the bioactive material and a fluid, and removing the fluid prior to the step of depositing the at least one porous layer (20).
80. The method according to claim 79, wherein the fluid is volatile, and the fluid removing step is carried out by allowing the fluid to evaporate from the structure (12) and bioactive material before the step of depositing the at least one porous layer (20).
81. The method according to claim 61, wherein the at least one additional coating layer (16) comprises a polymer selected from the group consisting essentially of polyamide, parylene or a parylene derivative, and the at least one coating layer (16) is applied to a thickness of about 50,000 to 500,000 .ANG..
82. The method according to claim 61, wherein the method is carried out with a structure (12) configured as a vascular stent.
83. The method according to claim 61, wherein the step of depositing the at least one bioactive material layer (18) is carried out with a bioactive material which includes at least one of: heparin, covalent 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, a glycoprotein IIb/IIIa inhibitor or another inhibitor of surface glycoprotein receptors, or another antiplatelet agent; colchicine or another antimitotic, or another microtubule inhibitor, dimethyl sulfoxide (DMSO), a retinoid or another antisecretory agent; cytochalasin or another actin inhibitor; or a remodeling inhibitor; deoxyribonucleic acid, an antisense nucleotide or another agent for molecular genetic intervention; methotrexate or another antimetabolite or antiproliferative agent; tamoxifen citrate, Taxol? or derivatives thereof, or other anti-cancer chemotherapeutic agents;
dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate or another dexamethasone derivative, or another anti-inflammatory steroid or non-steroidal anti-inflammatory agent; cyclosporin or another immunosuppressive agent; tripodal (a PDGF antagonist), angiopeptin (a growth hormone antagonist), angiogenin or other growth factors, or an anti-growth factor antibody, or another growth factor antagonist; 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, alpha tocopherol, superoxide dismutase, deferoxamine, a 21-amino steroid (lasaroid) or another free radical scavenger, iron chelator or antioxidant; a 14C-, 3H-, 131I-, 32P- or 36S-radiolabelled form or other radiolabelled form of any of the foregoing; estrogen or another sex hormone; AZT or other antipolymerases; acyclovir, famciclovir, rimantadine hydrochloride, ganciclovir sodium or other antiviral agents; 5-aminolevulinic acid, meta-tetrahydroxyphenylchlorin, hexadecafluoro zinc phthalocyanine, tetramethyl hematoporphyrin, rhodamine 123 or other 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 or other antibody target therapy agents; enalapril or other prodrugs; and gene therapy agents, or a mixture of any of these.
84. The method according to claim 61, wherein the step of depositing the at least one layer (18) of bioactive material is carried out so that the at least one layer (18) contains about 1 to 4 mg of the bioactive material per cm of the gross surface area of the structure (12).
85. The method according to claim 61, comprising the further step of surface processing the base material (14) before depositing the at least one bioactive material layer (18) over the structure (12).
86. An implantable medical device, comprising:
a structure adapted for introduction into a patient, the structure being comprised of a base material; wherein the base material comprises apertures within the surface of the base material and containing at least one bioactive material within said apertures wherein at least one porous layer is posited over said base material and said bioactive material contained within said apertures and wherein said porous layer is comprised of a polymer and having a thickness sufficient to provide a controlled release of the bioactive material.
87. The medical device according to claim 86 wherein said apertures are holes, slots, grooves or wells and may have the sectional shape of a half circle, of the letter V or of a truncated square.
88. The medical device according to claim 87 wherein said hole, slot, groove or well may be formed by etching using a photo resist pattern; by cutting with laser or EBM; or by stamping.
89. The medical device according to claim 88 wherein the same or different bioactive materials are contained within the holes, grooves, slots or wells.
90. The medical device according to claim 89 wherein the at least one bioactive material is selected from the group consisting essentially of heparin, covalent 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, a glycoprotein IIb/IIIa inhibitor or another inhibitor of surface glycoprotein receptors, or another antiplatelet agent; colchicine or another antimitotic, or another microtubule inhibitor, dimethylsulfoxide (DMSO), a retinoid or another antisecretory agent; cytochalasin or another actin inhibitor; or a remodeling inhibitor; deoxyribonucleic acid, an antisense nucleotide or another agent for molecular genetic intervention; methotrexate or another antimetabolite or antiproliferative agent; tamoxifen citrate, Taxol? or derivatives thereof, or other anti-cancer chemotherapeutic agents;
dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate or another dexamethasone derivative, or another anti-inflammatory steroid or non-steroidal anti-inflammatory agent;
cyclosporin or another immunosuppressive agent; tripodal (aPDGF
antagonist), angiopeptin (a growth hormone antagonist), angiogenin or other growth factors, or an anti-growth factor antibody, or another growth factor antagonist; 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, alpha tocopherol, superoxide dismutase, deferoxamine, a 21-amino steroid (lasaroid) or another free radical scavenger, iron chelator or antioxidant; a 14C-, 3H-, 131I-, 32P- or 36S-radiolabelled form or other radiolabelled form of any of the foregoing; estrogen or another sex hormone; AZT or other antipolymerases; acyclovir, famciclovir, rimantadine hydrochloride, ganciclovir sodium or other antiviral agents; 5-aminolevulinic acid, meta-tetrahydroxyphenylchlorin, hexadecaflouoro zinc phthalocyanine, tetramethyl hematoporphyrin, rhodamine 123 or other 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 or other antibody target therapy agents; enalapril or other prodrugs; and gene therapy agents, or a mixture of any of these.
91. The medical device according to claim 87 wherein the base material comprises a substantially non-porous coating and a porous layer overlies the holes, grooves, slots or wells containing at least one bioactive layer.
92. The medical device according to claim 91 wherein said device comprises further layers of bioactive materials and porous layer coatings.
93. An implantable medical device (10), comprising:
a structure (12) for introduction into a patient, the structure (12) being composed of base material (14);
at least one bioactive material posited on at least one part of the structure (12); and porous material(s) posited over the bioactive material (18), said porous material(s) being of a thickness and having properties to enable controlled release of the bioactive material.
94. The device according to claim 93, wherein said porous material(s) is/are polymeric and formed as one or more porous layers (20), each polymerized from a catalyst-free monomer vapor, and is/are formed over the bioactive material and any part of the structure surface not covered by the bioactive material.
95. The device according to claim 94, wherein the polymer is selected from a polyamide, polymers of parylene or derivatives thereof, polyalkylene oxide, polyalkylene glycol, polypropylene oxide, silicone based polymers, polymers of methane, tetrafluoroethylene or tetramethyldisiloxane or a polymer derived from photopolymerizeable monomers; and/or the base material (14) of the structure (12) includes 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 teraphthalate, polyurethane, polyamide, polyester, polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, or another biocompatible polymeric material, or mixtures or copolymers thereof; polylactic acid, polyglycolic acid or copolymers thereof, a polyanhydride, polycaprolactone, polyhydroxy-butyrate 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 mixture thereof; and/or the bioactive material includes at least one of: heparin, covalent 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, a glycoprotein IIb/IIIa inhibitor or another inhibitor of surface glycoprotein receptors, or another antiplatelet agent; colchicine or another antimitotic, or another microtubule inhibitor, dimethyl sulfoxide (DMSO), a retinoid or another antisecretory agent;
cytochalasin or another actin inhibitor; or a remodeling inhibitor; deoxyribonucleic acid, an antisense nucleotide or another agent for molecular genetic intervention; methotrexate or another antimetabolite or antiproliferative agent; tamoxifen citrate, Taxol? or derivatives thereof, or other anti-cancer chemotherapeutic agents; dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate or another dexamethasone derivative, or another anti-inflammatory steroid or non-steroidal anti-inflammatory agent; cyclosporin or another immunosuppressive agent; trapidal (a PDGF antagonist), angiogenin, angiopeptin (a growth hormone antagonist), a growth factor or an anti-growth factor antibody, or another growth factor antagonist; 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, alpha tocopherol, superoxide dismutase, deferoxamine, a 21-amino steroid (lasaroid) or another free radical scavenger, iron chelator or antioxidant; a 14C-, 3H-, 131I-, 32P- or 36S-radiolabelled form or other radiolabelled form of any of the foregoing; estrogen or another sex hormone; AZT or other antipolymerases; acyclovir, famciclovir, rimantadine hydrochloride, ganciclovir sodium or other antiviral agents; 5-aminolevulinic acid, meta-tetrahydroxyphenylchlorin, hexadecafluoro zinc phthalocyanine, tetramethyl hematoporphyrin, rhodamine 123 or other 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 or other antibody targeted therapy agents; gene therapy agents; and enalapril and other prodrugs, or a mixture of any of these.
96. The device (10) according to claim 94 or 95, wherein the thickness of the at least one porous layer (20) is about 5,000 to 250,000 .ANG., and the bioactive material(s) are, for example, present in about 1 to 4 mg. per cm2.
97. The device according to claim 93, 94, 95 or 96, further comprising at least one additional coating layer, for example, a less or substantially non-porous polymer layer (16), between the structure (12) and the at least one bioactive material layer (18).
98. The device (10) according to claim 97, wherein the polymer of the additional coating layer is selected from polyamide, polymers of parylene or derivatives thereof, or a polymer derived from photopolymerizable monomers of bisphenol A diglycidyl ether and acrylic acid or methacrylic acid, and the at least one additional coating layer (16) is about 50,000 to 500,000 .ANG. thick.
99. The device (10) according to claim 93, wherein the structure (12) is biocompatible and is configured as at least one of a stent, a vascular or other graft, a vascular or other graft in combination with a stent, heart valve, an orthopedic device, appliance, implant or replacement, or portion thereof; or a portion of any of these.
100. The device (10) according to claim 93, wherein different bioactive materials are posited at different locations on one surface or side of the structure, and are formed either directly on or in the structure, or partly on or in the structure at one location and partly on the porous layer, at another location.
101. The device (10) according to claim 100, wherein a third or different bioactive material is posited on or in another side of the structure, wherein the porous layer is positioned over the said third or different material and is also posited over one of the bioactive materials on the one side of the structure, and wherein another bioactive material, for example covalent heparin, is bonded to the outer surface of the porous layer.
102. The device (10) according to claim 93, 94, 95, 96, 97, 98, 99, 100, or 101, wherein the bioactive material(s) (18) is/are posited on said one part or surface in a geometric pattern, or in a discontinuous geometric pattern when the structure is a stent, or in a pattern of parallel lines, or a pattern of parallel lines but not on the tips of the stent, or are posited on or in adjacent parts of the same surface of the structure (12).
103. The device (10) according to claim 93, 94, 95, 96, 97, 98, 99, 100, 101, or 102, further comprising a connector (26) securing the at least one porous layer (20) to the base material (14) of the structure (12).
104. The device according to claim 101, 102, or 103, wherein the structure, for example a stent, is surface coated with a substantially non-porous coating layer have a thickness of about 50,000 .ANG. to about 500,000 .ANG. wherein the coating layer comprises a polymer selected from polyamide, a polymer derived from parylene or derivatives thereof, polyalkylene oxides, polyalkylene glycols, silicon based polymers, polymers derived from methane, tetrafluoro-ethylene, tetramethyldisiloxane, or polymers derived from photopolymerizeable monomers or mixtures of such polymers or copolymers thereof.
105. The device according to claim 100 or 101, wherein multiple layers comprise stent surfaces, such layers comprising alternating porous layers and at least one bioactive material layer and wherein different bioactive materials are posited on the different surfaces of the stent structure with the proviso that the same bioactive material is not posited on the different surfaces of the stent structure within the same layer and that a porous layer is posited over each bioactive material layer and the outermost layer may comprise either a porous layer or a bioactive material layer.
106. A method of making the device according to claim 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, or 105, wherein the bioactive material (18) layer is posited by a process of adsorption, absorption, vapor phase deposition, plasma deposition, chemically binding to the surface of the device, utilizing surfactants as an adhesion medium, electrode position, or combinations thereof.
107. The method according to claim 106, wherein the bioactive material (18) layer has been applied by vapor phase deposition, plasma deposition or by chemically binding to the substrate structure (12) and the bioactive material (18) is in the form of a powder, microencapsulated particles or a matrix incorporated material.
108. A method of making the device according to claim 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, or 107, wherein at least one porous layer (20) has been formed by sublimating and cracking di-p-xylylene or a derivative thereof to yield monomeric p-xylylene or a derivative thereof, and allowing the monomer so formed to simultaneously condense and polymerize over the bioactive material layer (18), the sublimation and cracking step, for example, being carried out with dichloro-di-p-xylylene.
109. The method according to claim 108, wherein the step of depositing the at least one layer (18) of a bioactive material is carried out by applying over the structure (12) a mixture of the bioactive material and a fluid, and removing the fluid prior to the step of depositing the at least one porous layer (20).
110. The method according to claim 109, wherein the fluid is volatile, and the fluid removing step is carried out by allowing the fluid to evaporate from the structure (12) and bioactive material before the step of depositing the at least one porous layer (20).
111. A device according to any one of claims 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, or 105, wherein the base material comprises apertures within the surface of the base material and the bioactive material(s) are positioned within the apertures, said apertures being in the form of holes, slots, grooves or wells or the like, for example having etched or stamped sectional shapes of a half circle, a letter V or of a truncated square, same or different bioactive materials being contained within the holes, grooves, slots or wells.
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US20070150047A1 (en) 2007-06-28
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US5824049A (en) 1998-10-20
CA2178541C (en) 2009-11-24
AU5588896A (en) 1996-12-19

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