Implantable medical device

Claim 2

The device according to claim 1, 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 active or bioactive material and any part of the structure surface not covered by said active or bioactive material.

Claim 3

The device according to claim 2, wherein the biocompatible polymer is selected from a polyamide, polymers or 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 said base material (14) of the structure (12) includes at least one of: stainless steel, tantalum, titanium, Nitionol, 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 active or 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; 60 Co, 192 Ir, 32 P, 111 In, 90 Y, 99 Tc 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 14 C-, 3 H-, 131 I-, 32 P- or 36 S-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.

Claim 4

The device (10) according to claim 2 or 3, wherein the thickness of the at least one porous layer (20) is about 5,000 to 250,000 Angstrom, and the active or bioactive material(s) are for example, present in about 1 to 4mg. per cm 2 .

Claim 5

The device according to claim 1,2,3 or 4, 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 active or bioactive material layer (18).

Claim 6

The device (10) according to claim 5, wherein the polymer of the said 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 Å thick.

Claim 7

The device (10) according to claim 1, 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.

Claim 8

A device according to claim 1, wherein different active or bioactive materials are positioned 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.

Claim 9

A device according to claim 8, wherein a third or different active or bioactive material is positioned on or in another side of the structure, wherein the porous layer is positioned over the said third or different material and is also positioned over one of the active or bioactive materials on the said one side of the structure, and wherein another active or bioactive material, for example covalent heparin, is bonded to the outer surface of the porous layer.

Claim 12

The device according to claim 9,10 or 11, wherein the structure, for example a stent is surface coated with a substantially non-porous coating layer having a thickness of about 50,000 Å to about 500,000 Å 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.

Claim 13

The device according to claim 8 or 9, 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.

Claim 15

The method according to claim 14, wherein the active or 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.

Claim 17

The method according to claim 16, 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).

Claim 18

The method according to claim 17, 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).