CA2435306A1 - Implants with fk506 - Google Patents
Implants with fk506 Download PDFInfo
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- CA2435306A1 CA2435306A1 CA002435306A CA2435306A CA2435306A1 CA 2435306 A1 CA2435306 A1 CA 2435306A1 CA 002435306 A CA002435306 A CA 002435306A CA 2435306 A CA2435306 A CA 2435306A CA 2435306 A1 CA2435306 A1 CA 2435306A1
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- implant
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- active agent
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Classifications
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- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
-
- 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
- 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
- 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
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
-
- 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
- A61L27/14—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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
-
- 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
Abstract
The invention relates to implants, in particular, for intracavernous or intravascular application, preferably for the treatment or prophylaxis of coronary or peripheral vascular constriction or occlusion, in particular constriction and stenoses or restenoses, preferably for the prophylaxis of restenoses, comprising FK506 in a chemically covalently or non-covalently bonded or physically fixed form, a method for production and use thereof.</S DOAB>
Claims (43)
1. An implant comprising FK506 in chemically covalently bound or noncovalently bound or physically immobilized form, and, optionally, at least one other active agent.
2. The implant as claimed in claim 1, characterized in that it is an intracavernous, preferably intravascular, implant.
3. The implant as claimed in either of claims 1 or 2, characterized in that the implant is suitable for the treatment or prophylaxis of coronary or peripheral vascular constrictions or occlusions, in particular of constrictions or stenoses or restenoses, preferably for the prophylaxis of restenosis.
4. The implant as claimed in any of claims 1 to 3, characterized in that the implant has at least one closed or perforated layer or surface which consists of a metal or a metal alloy and is homogeneous or formed from various strands.
5. The implant as claimed in any of claims 1 to 4, characterized in that the implant has at least one closed or perforated layer or surface which consists of a polymer and is homogeneous or formed from various strands.
6. The implant as claimed in claim 5, characterized in that at least one polymer layer covers completely or partly a closed or perforated layer or surface which consists of a metal or a metal alloy and is homogeneous or formed from various strands, preferably an optionally lattice-like structure consisting of a metal or a metal alloy.
7. The implant as claimed in claim 5, characterized in that the implant has at least one closed or perforated layer or surface which consists of a metal or a metal alloy and is homogeneous or formed from various strands, and at least one closed or perforated layer or surface which consists of a polymer and is homogeneous or formed from various strands.
8. The implant as claimed in claim 7, characterized in that the layer or surface consisting of a metal or a metal alloy is an optionally lattice-like structure consisting of a metal or a metal alloy, and/or the layer or surface consisting of a polymer is homogeneously closed or woven and/or is water- and/or corpuscle-impermeable, and/or the sequence of layers and surfaces is from the outside to the inside metal-polymer, polymer-metal, metal-polymer-metal or polymer-metal-polymer, and/or either the layer or surface consisting of a polymer is nonchemically (covalently or noncovalently) connected to a layer or surface consisting of a metal or a metal alloy, or the layer or surface consisting of a polymer is connected by means of an adhesive to the layer or surface consisting of a metal or a metal alloy.
9. The implant as claimed in any of claims 5 to 8, characterized in that the polymer is selected from Dacron; polytetrafluoroethylene (PTFE/Teflon), expandable or non-expandable; polyurethane;
methacrylate polymers; hydrogel or hydrogel/polyurethane blend, preferably from polytetrafluoroethylene (PTFE), expandable or non-expandable; or polyurethane; in particular from PTFE.
methacrylate polymers; hydrogel or hydrogel/polyurethane blend, preferably from polytetrafluoroethylene (PTFE), expandable or non-expandable; or polyurethane; in particular from PTFE.
10. The implant as claimed in any of claims 1 to 9, characterized in that the implant is a stent, a stent graft, a graft, a graft connector, a guide wire, a catheter or a catheter pump, preferably a stent, a scent graft, a graft or a graft connector, in particular a stem or a stet graft.
11. The implant as claimed in any of claims 1 to 10, characterized in that the implant is coated with FK506.
12. The implant as claimed in any of claims 4, 6 or 7 to 10, characterized in that the implant has a ceramic coating, in particular of aluminum oxide or iridium oxide, to which FK506 is bound.
13. The implant as claimed in claim 12, characterized in that the ceramic coating is completely or partly covered by a polymeric, preferably biodegradable, coating to which, optionally, FK506 and/or another active agent is bound or in which FK506 and/or another active agent has been.
dissolved before application of the coating.
dissolved before application of the coating.
14. The implant as claimed in any of claims 5 to 10 or 13, characterized in that the implant has a polymeric coating, in particular of methacrylate polymers, polyurethane, PTFE, hydrogel or hydrogel/polyurethane blend, in particular PTFE, to which FK506 is bound or in which FK506 has been dissolved before application of the coating.
15. The implant as claimed in any of claims 4, 6 or 7 to 10, characterized in that the metal of the implant has recesses which have been introduced by means of a laser and which are filled with FK506.
16. The implant as claimed in claim 15, characterized in that the metal provided with FK506-filled recesses or at least the recesses is/are coated with a biodegradable polymeric material, whereby, optionally, FK506 being bound to the polymeric coating, or FK506 having been dissolved in the polymeric material before application of the coating.
17. The implant as claimed in any of claims 11 to 16, characterized in that FK506 is present in the form of loaded nanoparticles or liposomes.
18. The implant as claimed in any of claims 1 to 10 which can be produced by a process in which a) an implant having at least one closed or perforated layer or surface which consists of a metal or a metal alloy and is homogeneous or formed from various strands, as claimed in any of claims 4, 6 or 7 to 10, which implant is coated with a ceramic coating, in particular of aluminum oxide, is employed or b) an implant having at least one closed or perforated layer or surface which consists of a polymer and is homogeneous or formed from various strands, as claimed in any of claims 5 to 10, is employed, or c) an implant as claimed in any of claims 1 to 10, which is coated with a coating which is polymerized or polymerizing on the surface, in particular of methacrylate polymers, polyurethane, PTFE, hydrogel or hydrogel/polyurethane blend, is employed or d) an implant as claimed in any of claims 4, 6 or 7 to 10 having at least one closed or perforated layer or surface which consists of a metal or a metal alloy and is homogeneous or formed from various strands, and into which recesses have been introduced by means of a laser, which are filled with FK506, and then the implant is coated with a biodegradable coating which is polymerized or polymerizing on the surface, is employed, e) then the implant according to a), b), c) or d) is brought into contact with an FK506 solution in aqueous or organic solvent, for example by sprinkling, spraying or immersing, optionally under vacuum, f) then, optionally, the implant is dried, preferably until the solvent from step e) is removed, g) then, optionally, step e), optionally followed by step f), is repeated, preferably several times, in particular 1 to 5 times, and, h) optionally, subsequently the implant is rinsed one or more times with water or isotonic saline, and, i) optionally, is subsequently dried.
19. The implant as claimed in claim 18, characterized in that in step e) FK506 is dissolved in alcohol, preferably in ethanol, in particular in a concentration of 0.5-5 g/l FK506 in ethanol and/or in step e) the implant is brought into contact with an FK506 solution in aqueous or organic solvent by immersing under vacuum preferably overnight, and/or steps f) and/or g) are not carried out and/or in step h) the implant is washed several times with saline and/or in step i) the implant is dried overnight.
20. The implant as claimed in claim 18, characterized in that in step e) the implant is introduced, preferably sterilely, into a preferably sterile vessel with a closure which can be perforated and which closes after completion of a perforation, for example into an injection vial, FK506 solution, is preferably sterilely introduced into the vessel, the latter is closed with the closure which can be perforated and which closes after completion of a perforation, a thin, preferably sterile, air-pervious ventilation tube, for example a cannula, is pushed perforatingly through the closure, a vacuum is applied and, preferably, the FK506 solution is agitated, and finally, preferably after about 12 h have elapsed, the thin, preferably sterile, air-pervious ventilation tube is removed and/or in that in step e) FK506 is dissolved in alcohol, preferably in ethanol, in particular in a concentration of 3.3 mg of FK506 in 1 ml of ethanol and/or in that the implant remains until used in the preferably sterile closed glass vessel from step e) and/or in that steps f) to i) are omitted.
21. The implant as claimed in any of claims 5 to 10 which can be produced by a process in which FK506 has been dissolved in the polymerization material before the formation of at least one closed or perforated layer or surface consisting of a polymer, or of a polymeric coating of the implant.
22. The implant as claimed in any of claims 1 to 21, characterized in that FK506 is released after implantation of the implant.
23. The implant as claimed in claim 22, characterized in that delayed release takes place.
24. The implant as claimed in claim 23, characterized in that FK506 is released from the implant over a period of 24 h, preferably 48 h, in particular more than 96 h, after implantation.
25. The implant as claimed in claim 23, characterized in that the FK506 e) is released within <48 h or f) over at least 48 h, preferably over at least 7 days, in particular over at least 2 and up to 21 days, from the implant after implantation, or in that g) the implant shows both release patterns d) and e).
26. The implant as claimed in any of claims 1 to 25, characterized in that the implant comprises at least one other active agent, preferably a pharmaceutically active agent, in particular another active agent selected from the following active agents and derivatives thereof (Group 1:) molsidomine, linsidomine, sodium nitroprusside, nitroglycerin or general NO
donors; stimulators of soluble guanylate cyclase (sGC), for example BAY 41-2272 (5-(cyclopropyl-2-[1-fluorobenzyl)-1H-pyrazolo[3,4-n]pyridin-3-yl]pyrimidin-4-ylamine); hydralazine, verapamil, diltiazem, nifedipine, nimodipine or other Ca2+ channel blockers; captopril, enalapril, lisinopril, quinapril or other inhibitors of angiotensin converting enzymes (angiotensin converting enzyme inhibitors); losartan, candesartan, irbesartan, valsartan or other antagonists of the angiotensin II receptor;
(Group 2:) dexamethasone, betamethasone, prednisone or other corticosteriods; 17-beta-estradiol; cyclosporin; mycophenolic acid;
VEGF, VEGF receptor activators; tranilast;
meloxicam, celebrex, vioxx or other COX-2 antagonists; indomethacin, diclofenac, ibuprofen, naproxen or other COX-1 inhibitors;
inhibitors of plasminogen activator 1 (plasminogen activator inhibitors-1) or serpins; thrombin inhibitors, for example hirudin, hirulog, agratroban, PPACK;
interleukin-10;
(Group 3:) sirolimus, rapamycin, SDZ RAD (40-O-(2-hydroxyethyl)rapamycin or other rapamycin derivatives; PDGF antagonists; paclitaxel or 7-hexanoyl-taxol; cisplatin; vinblastine;
mitoxantrone; combretastatin A4; topotecan;
methotrexate; flavopiridol;
actinomycin D; Rheopro/abciximab or probucol.
donors; stimulators of soluble guanylate cyclase (sGC), for example BAY 41-2272 (5-(cyclopropyl-2-[1-fluorobenzyl)-1H-pyrazolo[3,4-n]pyridin-3-yl]pyrimidin-4-ylamine); hydralazine, verapamil, diltiazem, nifedipine, nimodipine or other Ca2+ channel blockers; captopril, enalapril, lisinopril, quinapril or other inhibitors of angiotensin converting enzymes (angiotensin converting enzyme inhibitors); losartan, candesartan, irbesartan, valsartan or other antagonists of the angiotensin II receptor;
(Group 2:) dexamethasone, betamethasone, prednisone or other corticosteriods; 17-beta-estradiol; cyclosporin; mycophenolic acid;
VEGF, VEGF receptor activators; tranilast;
meloxicam, celebrex, vioxx or other COX-2 antagonists; indomethacin, diclofenac, ibuprofen, naproxen or other COX-1 inhibitors;
inhibitors of plasminogen activator 1 (plasminogen activator inhibitors-1) or serpins; thrombin inhibitors, for example hirudin, hirulog, agratroban, PPACK;
interleukin-10;
(Group 3:) sirolimus, rapamycin, SDZ RAD (40-O-(2-hydroxyethyl)rapamycin or other rapamycin derivatives; PDGF antagonists; paclitaxel or 7-hexanoyl-taxol; cisplatin; vinblastine;
mitoxantrone; combretastatin A4; topotecan;
methotrexate; flavopiridol;
actinomycin D; Rheopro/abciximab or probucol.
27. The implant as claimed in claim 26, characterized in that if the other active agent is selected from group 1 this active agent is released from the implant within the first 24 - 72 h after implantation and/or, if the other active agent is selected from group 2, the latter is released from the implant within the first 48 h - 21 days after implantation and/or, if the other active agent is selected from group 3, the latter is released from the implant within 14 days to 3 months after implantation.
28. A process for producing an implant as claimed in any of claims 1 to 25 with the following steps:
a) an implant having at least one closed or perforated layer or surface which consists of a metal or a metal alloy and is homogeneous or formed from various strands, as claimed in any of claims 4, 6 or 7 to 10, which implant is coated with a ceramic coating, in particular of aluminum oxide or irridium oxide, or b) an implant having at least one closed or perforated layer or surface which consists of a polymer and is homogeneous or formed from various strands, as claimed in any of claims 5 to 10, or c) an implant as claimed in any of claims 1 to 10, which is coated with a coating which is polymerized or polymerizing on the surface, in particular of methacrylate polymers, polyurethane, PTFE, hydrogel or hydrogel/polyurethane blend, or d) an implant as claimed in any of claims 4, 6 or 7 to 10 having at least one closed or perforated layer or surface which consists of a metal or a metal alloy and is homogeneous or formed from various strands, and into which recesses have been introduced by means of a laser, which are filled with FK506, and then the implant is coated with a preferably biodegradable coating which is polymerized or polymerizing on the surface, is employed, e) then the implant according to a), b), c) or d) is brought into contact with an FK506 solution in aqueous or organic solvent, for example by sprinkling, spraying or immersing, optionally under vacuum, f) then, optionally, the implant is dried, preferably until the solvent from step e) is evaporated, g) then, optionally, step e), optionally followed by step f), is repeated, preferably several times, in particular 1 to 5 times, and, h) optionally, subsequently the implant is rinsed one or more times with water or isotonic saline, and, i) optionally, is subsequently dried.
a) an implant having at least one closed or perforated layer or surface which consists of a metal or a metal alloy and is homogeneous or formed from various strands, as claimed in any of claims 4, 6 or 7 to 10, which implant is coated with a ceramic coating, in particular of aluminum oxide or irridium oxide, or b) an implant having at least one closed or perforated layer or surface which consists of a polymer and is homogeneous or formed from various strands, as claimed in any of claims 5 to 10, or c) an implant as claimed in any of claims 1 to 10, which is coated with a coating which is polymerized or polymerizing on the surface, in particular of methacrylate polymers, polyurethane, PTFE, hydrogel or hydrogel/polyurethane blend, or d) an implant as claimed in any of claims 4, 6 or 7 to 10 having at least one closed or perforated layer or surface which consists of a metal or a metal alloy and is homogeneous or formed from various strands, and into which recesses have been introduced by means of a laser, which are filled with FK506, and then the implant is coated with a preferably biodegradable coating which is polymerized or polymerizing on the surface, is employed, e) then the implant according to a), b), c) or d) is brought into contact with an FK506 solution in aqueous or organic solvent, for example by sprinkling, spraying or immersing, optionally under vacuum, f) then, optionally, the implant is dried, preferably until the solvent from step e) is evaporated, g) then, optionally, step e), optionally followed by step f), is repeated, preferably several times, in particular 1 to 5 times, and, h) optionally, subsequently the implant is rinsed one or more times with water or isotonic saline, and, i) optionally, is subsequently dried.
29. The process as claimed in claim 29, characterized in that in step e) FK506 is dissolved in alcohol, preferably in ethanol, in particular in a concentration of 0.5-5 g/l FK506 in ethanol and/or in that in step e) the implant is brought into contact with an FK506 solution in aqueous or organic solvent by immersing under vacuum preferably overnight, and/or in that steps f) and/or g) are not carried out, and/or in that in step h) the implant is washed several times with saline, and/or in that in step i) the implant is dried overnight.
30. The process as claimed in claim 28, characterized in that in step e) the implant is introduced, preferably sterilely, into a preferably sterile vessel with a closure which can be perforated and which closes after completion of a perforation, for example into an injection vial, FK506 solution, is preferably sterilely introduced into the vessel, the latter is closed with the closure which can be perforated and which closes after completion of a perforation, a thin, preferably sterilely, air-pervious ventilation tube, for example a cannula, is pushed perforatingly through.
the closure, a vacuum is applied and, preferably, the FK506 solution is agitated, and finally, preferably after about 12 h have elapsed, the thin, preferably sterile, air-pervious ventilation tube is removed and/or in step e) FK506 is dissolved in alcohol, preferably in ethanol, in particular in a concentration of 3.3 mg of FK506 in 1 ml of ethanol and/or in that the implant remains until used in the preferably sterile closed glass vessel from step e) and/or in that steps f) to i) are omitted.
the closure, a vacuum is applied and, preferably, the FK506 solution is agitated, and finally, preferably after about 12 h have elapsed, the thin, preferably sterile, air-pervious ventilation tube is removed and/or in step e) FK506 is dissolved in alcohol, preferably in ethanol, in particular in a concentration of 3.3 mg of FK506 in 1 ml of ethanol and/or in that the implant remains until used in the preferably sterile closed glass vessel from step e) and/or in that steps f) to i) are omitted.
31. The process for producing implants as claimed in any of claims 5 to 10, in which FK506 has been dissolved in the polymerization material before the formation of at least one closed or perforated layer or surface consisting of a polymer, or of a polymeric coating of the implant.
32. A process for producing implants coated with active agents, with the following steps:
a) the implant is introduced, preferably sterile, into a preferably sterile vessel with a closure which can be perforated and closes after completion of a perforation, for example an injection vial, b) preferably sterile solution of the active agent, preferably in an organic solvent with a low vapor pressure, in particular in alcohol such as ethanol or methanol, is introduced into the vessel, c) the vessel is closed with the closure which can be perforated and closes after completion of a perforation, d) a thin, preferably sterile, air-pervious ventilation tube, for example a cannula, is pushed perforatingly through the closure, e) optionally a vacuum is applied, whereby the active agent solution is preferably agitated, f) finally, preferably after about 12 h have elapsed, the thin, preferably sterilely, air-pervious ventilation tube is removed and, g) optionally, the implant is left until used in the preferably sterile closed glass vessel from step a).
a) the implant is introduced, preferably sterile, into a preferably sterile vessel with a closure which can be perforated and closes after completion of a perforation, for example an injection vial, b) preferably sterile solution of the active agent, preferably in an organic solvent with a low vapor pressure, in particular in alcohol such as ethanol or methanol, is introduced into the vessel, c) the vessel is closed with the closure which can be perforated and closes after completion of a perforation, d) a thin, preferably sterile, air-pervious ventilation tube, for example a cannula, is pushed perforatingly through the closure, e) optionally a vacuum is applied, whereby the active agent solution is preferably agitated, f) finally, preferably after about 12 h have elapsed, the thin, preferably sterilely, air-pervious ventilation tube is removed and, g) optionally, the implant is left until used in the preferably sterile closed glass vessel from step a).
33. The process as claimed in claim 32, characterized in that the implant from step a) has at least one metallic perforated or closed surface or layer, has a ceramic coating, has a polymeric coating and/or has at least one polymeric, perforated or closed surface or layer.
34. The process as claimed in either of claims 32 or 33, characterized in that the implant is a stent, stem graft, graft, graft connector, polymeric surface stent or catheter.
35. The process as claimed in any of claims 32 to 34, characterized in that the active agent is selected from pharmaceutical active agents such as, for example, immunosuppressants or antibiotics, is preferably selected from the following active agents and derivatives thereof (Group 1:) molsidomine, linsidomine, sodium nitroprusside, nitroglycerin or general NO
donors; stimulators of soluble guanylate cyclase (sGC), for example BAY 41-2272 (5-(cyclopropyl-2-[1-fluorobenzyl)-1H-pyrazolo[3,4-n]pyridin-3-yl]pyrimidin-4-ylamine); hydralazine, verapamil, diltiazem, nifedipine, nimodipine or other Ca2+ channel blockers; captopril, enalapril, lisinopril, quinapril or other inhibitors of angiotensin converting enzymes (angiotensin converting enzyme inhibitors-1); losartan, candesartan, irbesartan, valsartan or other antagonists of the angiotensin II receptor;
(Group 2:) dexamethasone, betamethasone, prednisone or corticosteriods; 17-beta-estradiol; cyclosporin; mycophenolic acid;
VEGF, VEGF receptor activators; tranilast;
meloxicam, celebrex, vioxx or other COX-2 antagonists; indomethacin, diclofenac, ibuprofen, naproxen or other COX-1 inhibitors;
inhibitors of plasminogen activator-1 (plasminogen activator inhibitors-1) or serpins;
thrombin inhibitors, for example hirudin, hirulog, agratroban, PPACK; interleukin-10;
(Group 3:) sirolimus, rapamycin, SDZ RAD (40-0-(2-hydroxyethyl)rapamycin or other rapamycin derivatives; PDGF antagonists; paclitaxel or 7-hexanoyl-taxol; cisplatin; vinblastine;
mitoxantrone; combretastatin A4; topotecan;
methotrexate; flavopiridol;
actinomycin D; Rheopro/abciximab or probucol, in particular is selected from (Group 1:) molsidomine, linsidomine, sodium nitroprusside, nitroglycerin or general NO
donors; stimulators of soluble guanylate cyclase (sGC), for example BAY 41-2272 (5-(cyclopropyl-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-n]pyridin-3-yl]pyrimidin-4-ylamine); captopril, enalapril, lisinopril, quinapril or other inhibitors of angiotensin converting enzymes (angiotensin converting enzyme inhibitors); losartan, candesartan, irbesartan, valsartan or other antagonists of the angiotensin II receptor;
(Group 2:) dexamethasone, betamethasone, prednisone or corticosteriods; FK506 (tacrolimus); VEGF, VEGF receptor activators;
inhibitors of plasminogen activator 1 (plasminogen activator inhibitors-1) or serpins;
(Group 3:) sirolimus, rapamycin, SDZ RAD (40-O-(2-hydroxyethyl)rapamycin or other rapamycin derivatives; PDGF-antagonists; paclitaxel or 7-hexanoyl-taxol; mitoxantrone; combretastatin A4; flavopiridol.
donors; stimulators of soluble guanylate cyclase (sGC), for example BAY 41-2272 (5-(cyclopropyl-2-[1-fluorobenzyl)-1H-pyrazolo[3,4-n]pyridin-3-yl]pyrimidin-4-ylamine); hydralazine, verapamil, diltiazem, nifedipine, nimodipine or other Ca2+ channel blockers; captopril, enalapril, lisinopril, quinapril or other inhibitors of angiotensin converting enzymes (angiotensin converting enzyme inhibitors-1); losartan, candesartan, irbesartan, valsartan or other antagonists of the angiotensin II receptor;
(Group 2:) dexamethasone, betamethasone, prednisone or corticosteriods; 17-beta-estradiol; cyclosporin; mycophenolic acid;
VEGF, VEGF receptor activators; tranilast;
meloxicam, celebrex, vioxx or other COX-2 antagonists; indomethacin, diclofenac, ibuprofen, naproxen or other COX-1 inhibitors;
inhibitors of plasminogen activator-1 (plasminogen activator inhibitors-1) or serpins;
thrombin inhibitors, for example hirudin, hirulog, agratroban, PPACK; interleukin-10;
(Group 3:) sirolimus, rapamycin, SDZ RAD (40-0-(2-hydroxyethyl)rapamycin or other rapamycin derivatives; PDGF antagonists; paclitaxel or 7-hexanoyl-taxol; cisplatin; vinblastine;
mitoxantrone; combretastatin A4; topotecan;
methotrexate; flavopiridol;
actinomycin D; Rheopro/abciximab or probucol, in particular is selected from (Group 1:) molsidomine, linsidomine, sodium nitroprusside, nitroglycerin or general NO
donors; stimulators of soluble guanylate cyclase (sGC), for example BAY 41-2272 (5-(cyclopropyl-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-n]pyridin-3-yl]pyrimidin-4-ylamine); captopril, enalapril, lisinopril, quinapril or other inhibitors of angiotensin converting enzymes (angiotensin converting enzyme inhibitors); losartan, candesartan, irbesartan, valsartan or other antagonists of the angiotensin II receptor;
(Group 2:) dexamethasone, betamethasone, prednisone or corticosteriods; FK506 (tacrolimus); VEGF, VEGF receptor activators;
inhibitors of plasminogen activator 1 (plasminogen activator inhibitors-1) or serpins;
(Group 3:) sirolimus, rapamycin, SDZ RAD (40-O-(2-hydroxyethyl)rapamycin or other rapamycin derivatives; PDGF-antagonists; paclitaxel or 7-hexanoyl-taxol; mitoxantrone; combretastatin A4; flavopiridol.
36. The use of an implant as claimed in any of claims 1 to 27 for the treatment or prophylaxis of coronary or peripheral vascular constrictions or occlusions, in particular of constrictions or stenoses or restenoses, preferably for the prophylaxis of restenosis.
37. The use of FK506 for the coating or for the production of an implant for the treatment or prophylaxis of coronary or peripheral vascular constructions or occlusions, in particular of constrictions or stenoses or restenoses, preferably for the prophylaxis of restenosis.
38. The use as claimed in claim 37, characterized in that the implant is a stent, a stent graft, a graft, a graft connector, a guide wire, a catheter or a catheter pump, preferably a stent, a stent graft, a graft or a graft connector, in particular a stent or a stent graft or a polymeric surface stent.
39. The use as claimed in either of claims 37 or 38, characterized in that the FK506 is bound or attached to the implant in such a way that it is released, preferably in a delayed manner, from the implant after implantation.
40. The use of FK506 for the treatment or prophylaxis of coronary or peripheral vascular constrictions or occlusions, in particular of constrictions or stenoses or restenoses, preferably for the prophylaxis of restenosis.
41. A polymeric surface stent comprising at least one physiologically and/or pharmaceutically active active agent in chemically covalently bound or non-covalently bound or physically immobilized form.
42. The polymeric surface stent as claimed in claim 41, characterized in that the active agent is selected from pharmaceutically active agents such as, for example, immunosuppressants or antibiotics, is preferably selected from the following active agents and derivatives thereof (Group 1:) molsidomine, linsidomine, sodium nitroprusside, nitroglycerin or general NO
donors; stimulators of soluble guanylate cyclase (sGC), for example BAY 41-2272 (5-(cyclopropyl-2-[1-fluorobenzyl)-1H-pyrazolo[3,4-n]pyridin-3-yl]pyrimidin-4-ylamine); hydralazine, verapamil, diltiazem, nifedipine, nimodipine or other Ca2+ channel blockers; captopril, enalapril, lisinopril, quinapril or other inhibitors of angiotensin converting enzymes (angiotensin converting enzyme inhibitors); losartan, candesartan, irbesartan, valsartan or other antagonists of the angiotensin II receptor;
(Group 2:) dexamethasone, betamethasone, prednisone or corticosteriods; 17-beta-estradiol; cyclosporin; mycophenolic acid;
VEGF, VEGF receptor activators; tranilast;
meloxicam, celebrex, vioxx or other COX-2 antagonists; indomethacin, diclofenac, ibuprofen, naproxen or other COX-1 inhibitors;
inhibitors of plasminogen activator-1 (plasminogen activator inhibitors-1) or serpins; thrombin inhibitors, for example hirudin, hirulog, agratroban, PPACK;
interleukin-10;
(Group 3:) sirolimus, rapamycin, SDZ RAD (40-0-(2-hydroxyethyl)rapamycin or other rapamycin derivatives; PDGF antagonists; paclitaxel or 7-hexanoyl-taxol; cisplatin; vinblastine;
mitoxantrone; combretastatin A4; topotecan;
methotrexate; flavopiridol;
actinomycin D; Rheopro/abciximab or probucol, in particular is selected from (Group 1:) molsidomine, linsidomine, sodium nitroprusside, nitroglycerin or general NO
donors; stimulators of soluble guanylate cyclase (sGC), for example BAY 41-2272 (5-(cyclopropyl-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-n]pyridin-3-yl]pyrimidin-4-ylamine); captopril, enalapril, lisinopril, quinapril or other inhibitors of angiotensin converting enzymes (angiotensin converting enzyme inhibitors); losartan, candesartan, irbesartan, valsartan or other antagonists of the angiotensin II receptor;
(Group 2:) dexamethasone, betamethasone, prednisone or corticosteriods; FK506 (tacrolimus); VEGF, VEGF receptor activators;
inhibitors of plasminogen activator 1 (plasminogen activator inhibitors-1) or serpins;
(Group 3:) sirolimus, rapamycin, SDZ RAD (40-0-(2-hydroxyethyl)rapamycin or other rapamycin derivatives; PDGF-antagonists; paclitaxel or 7-hexanoyl-taxol; mitoxantrone; combretastatin A4; flavopiridol;
and/or in that the polymeric surface stent comprises at least two, preferably 2 or 3, physiologically and/or pharmaceutically active active agents selected from one of groups 1 to 3, preferably a maximum of one active agent from one group.
donors; stimulators of soluble guanylate cyclase (sGC), for example BAY 41-2272 (5-(cyclopropyl-2-[1-fluorobenzyl)-1H-pyrazolo[3,4-n]pyridin-3-yl]pyrimidin-4-ylamine); hydralazine, verapamil, diltiazem, nifedipine, nimodipine or other Ca2+ channel blockers; captopril, enalapril, lisinopril, quinapril or other inhibitors of angiotensin converting enzymes (angiotensin converting enzyme inhibitors); losartan, candesartan, irbesartan, valsartan or other antagonists of the angiotensin II receptor;
(Group 2:) dexamethasone, betamethasone, prednisone or corticosteriods; 17-beta-estradiol; cyclosporin; mycophenolic acid;
VEGF, VEGF receptor activators; tranilast;
meloxicam, celebrex, vioxx or other COX-2 antagonists; indomethacin, diclofenac, ibuprofen, naproxen or other COX-1 inhibitors;
inhibitors of plasminogen activator-1 (plasminogen activator inhibitors-1) or serpins; thrombin inhibitors, for example hirudin, hirulog, agratroban, PPACK;
interleukin-10;
(Group 3:) sirolimus, rapamycin, SDZ RAD (40-0-(2-hydroxyethyl)rapamycin or other rapamycin derivatives; PDGF antagonists; paclitaxel or 7-hexanoyl-taxol; cisplatin; vinblastine;
mitoxantrone; combretastatin A4; topotecan;
methotrexate; flavopiridol;
actinomycin D; Rheopro/abciximab or probucol, in particular is selected from (Group 1:) molsidomine, linsidomine, sodium nitroprusside, nitroglycerin or general NO
donors; stimulators of soluble guanylate cyclase (sGC), for example BAY 41-2272 (5-(cyclopropyl-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-n]pyridin-3-yl]pyrimidin-4-ylamine); captopril, enalapril, lisinopril, quinapril or other inhibitors of angiotensin converting enzymes (angiotensin converting enzyme inhibitors); losartan, candesartan, irbesartan, valsartan or other antagonists of the angiotensin II receptor;
(Group 2:) dexamethasone, betamethasone, prednisone or corticosteriods; FK506 (tacrolimus); VEGF, VEGF receptor activators;
inhibitors of plasminogen activator 1 (plasminogen activator inhibitors-1) or serpins;
(Group 3:) sirolimus, rapamycin, SDZ RAD (40-0-(2-hydroxyethyl)rapamycin or other rapamycin derivatives; PDGF-antagonists; paclitaxel or 7-hexanoyl-taxol; mitoxantrone; combretastatin A4; flavopiridol;
and/or in that the polymeric surface stent comprises at least two, preferably 2 or 3, physiologically and/or pharmaceutically active active agents selected from one of groups 1 to 3, preferably a maximum of one active agent from one group.
43. The polymeric surface stent as claimed in claim 42, characterized in that if the other active agent is selected from group 1 this active agent is released from the implant within the first 24-72 h after implantation, and/or, if the other active agent is selected from group 2, this active agent is released from the implant within the first 48 h-21 days after implantation, and/or, if the other active agent is selected from group 3, this active agent is released from the implant within 14 days to 3 months after implantation.
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE2001107339 DE10107339A1 (en) | 2001-02-16 | 2001-02-16 | Implant used for treating vascular narrowing or occlusion, especially for controlling restenosis contains FK506 in chemically bound or physically fixed form |
| DE10107339.9 | 2001-02-16 | ||
| DE10127011.9 | 2001-06-05 | ||
| DE2001127011 DE10127011A1 (en) | 2001-06-05 | 2001-06-05 | Implant used for treating vascular narrowing or occlusion, especially for controlling restenosis contains FK506 in chemically bound or physically fixed form |
| DE10127330.4 | 2001-06-06 | ||
| DE2001127330 DE10127330A1 (en) | 2001-06-06 | 2001-06-06 | Implant used for treating vascular narrowing or occlusion, especially for controlling restenosis contains FK506 in chemically bound or physically fixed form |
| PCT/EP2002/001707 WO2002065947A2 (en) | 2001-02-16 | 2002-02-18 | Implants with fk506 for prophylaxis and treatment of restonoses |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2435306A1 true CA2435306A1 (en) | 2002-08-29 |
| CA2435306C CA2435306C (en) | 2010-12-21 |
Family
ID=27214297
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2435306A Expired - Fee Related CA2435306C (en) | 2001-02-16 | 2002-02-18 | Implants with fk506 |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US8187320B2 (en) |
| EP (2) | EP1842569A3 (en) |
| JP (1) | JP4290985B2 (en) |
| KR (2) | KR100994543B1 (en) |
| CN (1) | CN100469394C (en) |
| AT (1) | ATE368482T1 (en) |
| AU (2) | AU2002233342B2 (en) |
| BR (1) | BR0207321A (en) |
| CA (1) | CA2435306C (en) |
| DE (1) | DE50210591D1 (en) |
| IL (2) | IL156887A0 (en) |
| NZ (1) | NZ540000A (en) |
| WO (1) | WO2002065947A2 (en) |
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| US8084076B2 (en) | 2003-02-21 | 2011-12-27 | Sorin Biomedica Cardio S.R.L. | Process for producing stents and corresponding stents |
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- 2002-02-18 KR KR1020037010759A patent/KR100994543B1/en not_active IP Right Cessation
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- 2002-02-18 DE DE50210591T patent/DE50210591D1/en not_active Expired - Lifetime
- 2002-02-18 EP EP07113417A patent/EP1842569A3/en not_active Withdrawn
- 2002-02-18 AU AU2002233342A patent/AU2002233342B2/en not_active Ceased
- 2002-02-18 JP JP2002565512A patent/JP4290985B2/en not_active Expired - Fee Related
- 2002-02-18 CA CA2435306A patent/CA2435306C/en not_active Expired - Fee Related
- 2002-02-18 KR KR1020097025020A patent/KR20090130879A/en not_active Application Discontinuation
- 2002-02-18 WO PCT/EP2002/001707 patent/WO2002065947A2/en active IP Right Grant
- 2002-02-18 BR BR0207321-8A patent/BR0207321A/en not_active IP Right Cessation
- 2002-02-18 CN CNB028050916A patent/CN100469394C/en not_active Expired - Fee Related
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- 2002-02-18 IL IL15688702A patent/IL156887A0/en unknown
- 2002-02-18 AT AT02700248T patent/ATE368482T1/en not_active IP Right Cessation
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2003
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- 2003-08-15 US US10/641,787 patent/US8187320B2/en not_active Expired - Fee Related
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2008
- 2008-01-22 AU AU2008200300A patent/AU2008200300B2/en not_active Ceased
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2012
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| US8084076B2 (en) | 2003-02-21 | 2011-12-27 | Sorin Biomedica Cardio S.R.L. | Process for producing stents and corresponding stents |
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| US20120239139A1 (en) | 2012-09-20 |
| CN1547490A (en) | 2004-11-17 |
| IL156887A (en) | 2009-09-01 |
| CA2435306C (en) | 2010-12-21 |
| KR100994543B1 (en) | 2010-11-16 |
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| US8187320B2 (en) | 2012-05-29 |
| JP2004531299A (en) | 2004-10-14 |
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| EP1372753B1 (en) | 2007-08-01 |
| WO2002065947A3 (en) | 2003-09-18 |
| JP4290985B2 (en) | 2009-07-08 |
| KR20040011463A (en) | 2004-02-05 |
| EP1842569A2 (en) | 2007-10-10 |
| WO2002065947A2 (en) | 2002-08-29 |
| AU2002233342B2 (en) | 2007-10-25 |
| EP1842569A3 (en) | 2010-03-03 |
| IL156887A0 (en) | 2004-02-08 |
| AU2008200300B2 (en) | 2011-04-21 |
| DE50210591D1 (en) | 2007-09-13 |
| AU2008200300A1 (en) | 2008-02-14 |
| CN100469394C (en) | 2009-03-18 |
| ATE368482T1 (en) | 2007-08-15 |
| KR20090130879A (en) | 2009-12-24 |
| BR0207321A (en) | 2004-02-10 |
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