Implanted Device

Patent metadata

Field	Value
Publication number	US-2019008996-A1
Application number	US-201616068122-A
Country	US
Kind code	A1
Filing date	Jun 27, 2016
Priority date	Jan 8, 2016
Publication date	Jan 10, 2019
Grant date	—

Abstract

Disclosed is an implanted device, comprising a device base body and an active drug, wherein the device base body is pure zinc and/or a zinc alloy, the zinc content in the device base body is 0.1-100%, and the active drug comprises anti-allergic drugs. After the implantation of the implanted device into the human body, the surrounding tissues of the implant would not have a clear hypersensitive reaction due to the presence of the anti-allergic drugs, and the implanted device can be used to be implanted into the body for supporting organ chambers, to fill the hollow chambers of the organs and tissues or as orthopaedic implants etc.

First claim

1 . An implanted device, comprising a device substrate and an active drug, wherein the device substrate is pure zinc and/or a zinc alloy; the device substrate contains 0.1 to 100 percent of zinc; and the active drug comprises an anti-allergic drug.

2 . The implanted device according to claim 1 , wherein the implanted device further comprises a zinc complexing agent; wherein the zinc complexing agent and the pure zinc or the zinc alloy in the device substrate form a complex in body fluid.

3 . The implanted device according to claim 2 , wherein the zinc complexing agent contains at least one coordination group; the coordination group is selected from the group consisting of hydroxyl on polycyclic aromatic hydrocarbon, sulfydryl, amino, an aromatic heterocyclic group, nitroso, carbonyl, sulpho, a phosphate group and an organic phosphorus group; the hydroxyl on the polycyclic aromatic hydrocarbon is a phenolic hydroxyl; and the aromatic heterocyclic group is selected from the group consisting of furyl, pyrryl, imidazolyl, triazolyl, thienyl, thiazolyl, pyridyl, a pyridone group, pyranyl, a pyrone group, pyrimidyl, pyridazinyl, pyrazinyl, quinolyl, isoquinolyl, phthalazinyl, pteridyl, indolyl, purinyl and a phenanthroline group.

4 . The implanted device according to claim 3 , wherein the zinc complexing agent is selected from the group consisting of: a hydroxyl-on-polycyclic aromatic hydrocarbon-containing polydentate ligand including 8-hydroxyquinoline, 8-hydroxyquinaldine, 4,5-dioxybenzene-1,3-sodium disulfonate, 4-[3,5-bis-hydroxyphenyl-1H-1,2,4-triazole]-benzoic acid and 1-(2-pyridine azo)-2-naphthol; a sulfydryl-containing complexing agent including 8 -mercaptoquinoline, mercaptoacetic acid, propyl disulfide and 5-methyl-2-mercapto mercaptobenzoate; an amido-containing complexing agent including ethidene diamine, triethylene tetramine, ethylenediamine tetraacetic acid, ethylene diamine tetraacetic acid tetrasodium, triethylene tetramine and N-(2-ethoxyl)ethidene diamine-N,N′,N′-triacetic acid or N′-(5-[[4-[[[5-(acetyl hydroxylamine)amyl]ammonia]-1,4-dioxobutyl]hydroxylamine]amyl]-N-(5-amido amyl)-N-hydroxyl succinamide: an aromatic heterocyclic group-containing complexing agent including phenanthroline, dipyridyl, porphyrin, porphin, chlorophyll, hemoglobin or 1,2-dimethyl-3-hydroxyl-4-pyridone; a nitroso-containing polydentate ligand including 1-nitroso-2-naphthol or 1-nitroso-2-naphthol-6-sodium sulfonate; a sulpho-containing polydentate ligand including sulfosalicylic acid and 8-hydroxyquinoline-5-sulphonic acid; a phosphate group-containing polydentate ligand including pyrophosphoric acid, tripolyphosphoric acid, hexametaphosphoric acid, polyphosphoric acid, sodium pyrophosphate, sodium hexametaphosphate or ammonium polyphosphate; an organic phosphorus-containing complexing agent including potassium diethylenetriamine pentamethylene phosphonate or sodium ethylenediamine tetramethylene phosphonate; a carbonyl-containing ligand including carboxylic acid and salt thereof, anhydride, ester, amide, polycarboxylic acid or polyanhydride, and further the carbonyl-containing ligand including gluconic acid, oxalic acid, tartaric acid, malic acid, oxaloacetic acid, fumaric acid, maleic acid, citric acid, nitrilotriacetic acid, diethylene triamine pentacarboxylic acid, alginic acid, glutamic acid, aspartic acid, ornithine, lysine, 1,2-diaminocyctohexane-N,N,N′,N′-tetraacetic acid, potassium citrate, calcium citrate, monoglyceride citrate, acetylsalicylic acid, sulpho salicylamide, polyaspartic acid, polyglutamic acid, poly-ornithine, polylysine or polymaleic anhydride.

5 . The implanted device according to claim 1 , wherein the anti-allergic drug is at least one of an antihistamine type anti-allergic drug, an antileukotriens drug, a mast cell membrane stabilizer, a glucocorticoids anti-allergic drug or an immunoregulation anti-allergic drug.

6 . The implanted device according to claim 5 , wherein the anti-allergic drug is selected from the group consisting of chlortrimeton, diphenhydramine, promethazine hydrochloride, cetirizine, clarityne, mizolastine, ebastine, astemizole, terfenadine, desloratadine, fexofenadine, cyproheptadine, ketotifen, levocetirizine, meclizine, efletirizine, carebastine, azelastine, decloxizine, chlorcyclizine, amlexanox, acrivastine, azatadine, mequitazine, levocabastine, setastine, sequifenadine, deptropine, pizotifen, pyrilamine, ranitidine, emedastine, epinastine, promethazine, montelukast, zafirlukast, tomelukast, zileuton, amlexanox, ibudilast, pemirolast, doxepin verlukast, docebenone, sodium cromoglycate, sodium hydroxypropylcromate, nedocromil sodium, tranilast, tiaramide, repirinast, bufrolin, zaprinast, tazanolast, ozagrel, repirinast, dexamethasone, methylprednisolone, hydrocortisone, triamcinolone acetonide, corticosteroids, vitamin C, calcium, coenzyme Q10 or trypsin chymotrypsin.

7 . The implanted device according to claim 1 , wherein the content of the anti-allergic drug on the surface of the device substrate ranges from 10 to 500 ug/cm 2 , further 100 to 300 ug/cm 2 .

8 . The implanted device according to claim 1 , wherein the active drug further comprises at least one of an anti-restenosis drug, an anti-hyperplasia drug, an antiplatelet drug or an anti-inflammatory reaction drug.

9 . The implanted device according to claim 1 wherein the active drug is in contact with the device substrate in at least one of the following manners: the active drug at least partially covers the surface of the device substrate; or the device substrate has micro pores, and the active drug is arranged in the micro pores of the device substrate; or the device substrate is provided with a gap, a hole or a groove, and the active drug is arranged in the gap, the hole or the groove of the device substrate; or the device substrate has an inner cavity, and the inner cavity of the device substrate is filled with the active drug.

10 . The implanted device according to claim 9 , wherein the active drug exists in the form of a coating; and the coating has a thickness in the range of 2 to 50 μm, further 5 to 25 μm.

11 . The implanted device according to claim 10 , wherein the coating further comprises a polymer carrier; the polymer carrier is a degradable polymer, and the degradable polymer is formed by physically blending one or several of polylactic acid, poly glycolic acid, polyethylene succinate), poly(beta-hydroxybutyrate), polycaprolactone, polyethylene glycol adipate, a polylactic acid-glycolic acid copolymer or polypentanoate, or is formed by copolymerizing one or several of the polylactic acid, the polyglycolic acid, the poly(ethylene succinate), the poly(beta-hydroxybutyrate), the polycaprolactone, the polyethylene glycol adipate, the polylactic acid-glycollic acid copolymer or the polypentanoate. Or the polymer carrier is a nondegradable polymer, and the nondegradable polymer is formed by physically blending one or several of polyurethane, polycarbonate, poly(methyl methacrylate), polystyrene, polybutylene or poly(butyl methacrylate), or is formed by copolymerizing one or several of the polyurethane, the polycarbonate, the poly(methyl methacrylate), the polystyrene, the polybutylene or the poly(butyl methacrylate). Or the polymer carrier is formed by physically blending one or several of monomers of the degradable polymers and monomers of the nondegradable polymers, or is formed by copolymerizing one or several of the monomers of the degradable polymers and the monomers of the nondegradable polymers,

12 . The implanted device according to claim 10 , wherein a mass ratio of the polymer carrier to the active drug ranges from 50:1-1:20, further 10:1-1:10.

13 . The impla

Assignees

• Lifetech Scient Shenzhen Co

Inventors

• Zhang Deyuan
• Chen Liping
• Qi Haiping
• Sun Hongtao
• Hu Jun
• Lin Wenjiao

Classifications

• A61K6/84

  comprising metals or alloys · CPC title

• C22F1/16

  of other metals or alloys based thereon · CPC title

• A61L27/00

  Materials for {grafts or} prostheses or for coating {grafts or} prostheses (dental prostheses A61C13/00; shape or structure of prostheses A61F2/00; use of preparations for artificial teeth A61K6/80; artificial kidneys A61M1/14) · CPC title

• C22C1/02

  by melting {(C22C1/1036 takes precedence)} · CPC title

• A61B17/68

  Internal fixation devices {, including fasteners and spinal fixators, even if a part thereof projects from the skin (bone staples A61B17/0642)} · CPC title