Claims for Patent: 8,257,729

Summary for Patent: 8,257,729

Title:	Implants with membrane diffusion-controlled release of active ingredient
Abstract:	An implant for implantation in a human or animal body having a structure comprising a) an implant base body; b) a primer layer which is partially or completely applied to the surface of the implant; c) an active ingredient layer consisting of one, two, three or more active ingredients applied entirely or partially to the surface of the primer layer; and d) a diffusion-controlling layer which is applied partially or entirely to the active ingredient layer, and optionally to the primer layer, wherein diffusion of the active ingredients of the active ingredient layer is controlled. Also disclosed is a manufacturing method for an implant.
Inventor(s):	Schmitz; Klaus-Peter (Warnemuende, DE), Behrend; Detlef (Rostock, DE), Sternberg; Katrin (Rostock, DE), Grabow; Niels (Rostock, DE), Harder; Claus (Uttenreuth, DE), Klocke; Bjoern (Zurich, CH), Kroemer; Heyo K. (Neuenkirchen, DE), Weitschies; Werner (Neuenkirchen, DE)
Assignee:	Biotronik VI Patent AG (Baar, CH) Universitaet Rostock (Rostock, DE) Universitaet Greifswald (Greifswald, DE)
Application Number:	12/331,567
Patent Claims:	1. An implant having a structure for implantation in a human or animal body, the implant comprising: a) an implant base body; b) a primer layer applied at least partially to the surface of the implant; c) an active ingredient layer consisting of one or more active ingredients applied to at least a portion of the surface of the primer layer; and d) a diffusion-controlling layer applied to at least a portion of the active ingredient layer and a portion of the primer layer, wherein diffusion of the active ingredients of the active ingredient layer is controlled. 2. The implant of claim 1, wherein the primer layer is one or more materials selected from the group consisting of silicon carbide (SiC), diamond-like carbon (DLC), pyrolytic carbon (pyC), a parylene, glycocalix, and hydroxyapatite. 3. The implant of claim 1, wherein the diffusion-controlling layer comprises one or more polymers selected from the group consisting of a polyester, a polyurethane, a silicon, a polyorganophosphazene, a polymethacrylate, a polystyrene block copolymer, a polyethylene-co-vinyl acetate, a polyethylene terephthalate or a blend or a copolymer thereof, and a phosphorylcholine polymer or polysaccharide. 4. The implant of claim 1, wherein the one or more active ingredients of the active ingredient layer are each independently selected from the group consisting of an antiphlogistic, a cytostatic, an immunosuppressant, a platelet aggregation inhibitor, a statin, an estrogen, a lipid regulator, a vasodilator, a calcium channel blocker, a calcineurin inhibitor, an anti-inflammatory drug, an anti-allergic, an oligonucleotide, an endothelium-forming agent, a steroid, a protein, a peptide, a proliferation inhibitor, an analgesic, and an antirheumatic. 5. The implant of claim 1, wherein the implant base body is selected from the group consisting of a heart pacemaker, a brain pacemaker, a heart implant, a pacemaker electrode, a defibrillation electrode, a cochlear implant, an implant for dental medicine, a depot implant that serves to form a depot of an active ingredient, a biodegradable or permanent coronary or peripheral stent, a biodegradable or permanent stent for an internal cavity, and a local drug delivery implant. 6. The implant of claim 1, wherein the implant base body is a permanent or biodegradable coronary stent. 7. A method for manufacturing an implant, the method comprising: a) providing an implant having a structure for implantation in a human or animal body, the implant comprising: (i) an implant base body; (ii) a preparation for a primer layer comprising one or more primer materials; (iii) a preparation for an active ingredient layer comprising one or more active ingredients; and (iv) a preparation for a diffusion-controlling layer comprising one or more polymers and one or more solvents; b) coating at least a portion of the implant base body with the preparation for the primer layer; c) coating a portion of the at least partially coated implant base body from step b) with the preparation for the active ingredient layer; and d) coating at least a portion of the at least partially coated implant base body from c) with the preparation for the diffusion-controlling layer and a portion of the primer layer. 8. The implant of claim 3, wherein the diffusion controlling layer polymer is one or more materials selected from the group consisting of polydioxanone, polyglycolide, polycaprolactone, polyhydroxyvaleric acid, a polyhydroxybutyric acid, a polylactide, and a copolymer of the foregoing. 9. The implant of claim 3, wherein the diffusion controlling layer polysaccharide is one or more materials selected from the group consisting of chitosan, hyaluronic acid, heparin, dextran and cellulose. 10. The implant of claim 4, wherein the antiphlogitic is selected from the group consisting of dexamethasone, methylprednisolone and diclofenac. 11. The implant of claim 4, wherein the cystostaic is selected from the group consisting of paclitaxel, colchicine, actinomycin D and methotrexate. 12. The implant of claim 4, wherein the immunosuppressant is selected from the group consisting of a limus compound, sirolimus (rapamycin), zotarolimus (ABT-578), tacrolimus (FK-506), everolimus, biolimus, biolimus A9, pimecrolimus, cyclosporin A and mycophenolic acid. 13. The implant of claim 4, wherein the platelet aggregation inhibitor is abciximab or iloprost. 14. The implant of claim 4, wherein the statin is selected from the group consisting of simvastatin, mevastatin, atorvastatin, lovastatin, pitavastatin and fluvastatin. 15. The implant of claim 4, wherein the estrogen is selected from the group consisting of 17.beta.-estradiol, daidzein and genistein.

Details for Patent 8,257,729

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REOPRO	abciximab	Injection	103575	12/22/1994		2027-12-10