Implantable medical device
First Claim
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1. An implantable medical device comprising:
- an orthopedic device substrate having a surface;
a coating on the surface of the substrate, wherein the coating consists essentially of a water soluble antibiotic drug, wherein the solubility of the drug, measured by making a saturated solution of the drug in deionised water at 25 C, is at least 40 g·
l−
1; and
wherein the water soluble antibiotic drug is present on the surface of the substrate in a dosage of at least about 250 μ
g·
cm−
2; and
,a protective layer which overlies the coating, the protective layer comprising a polymer having a weight average molecular weight of not more than 40,000 g/mol, wherein the polymer comprises polylactic acid, polyglycolic acid or a lactic acid/glycolic acid copolymer;
wherein the thickness of the protective layer is not more than about 20 μ
m;
wherein the device is configured to release at least 90% of the drug within 1 day;
wherein the device is configured to contact bone; and
,wherein the device is configured to control infection at an orthopedic surgical site.
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Abstract
An implantable medical device, which comprises a device substrate, a coating on the substrate which includes a drug which is highly soluble in water, and a protective layer which overlies the coating. The protective layer comprises a polymer selected from the group consisting of polylactic acid, polyglycolic acid and a lactic acid/glycolic acid copolymer having a weight average molecular weight of not more than 40,000.
21 Citations
20 Claims
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1. An implantable medical device comprising:
-
an orthopedic device substrate having a surface; a coating on the surface of the substrate, wherein the coating consists essentially of a water soluble antibiotic drug, wherein the solubility of the drug, measured by making a saturated solution of the drug in deionised water at 25 C, is at least 40 g·
l−
1; and
wherein the water soluble antibiotic drug is present on the surface of the substrate in a dosage of at least about 250 μ
g·
cm−
2; and
,a protective layer which overlies the coating, the protective layer comprising a polymer having a weight average molecular weight of not more than 40,000 g/mol, wherein the polymer comprises polylactic acid, polyglycolic acid or a lactic acid/glycolic acid copolymer; wherein the thickness of the protective layer is not more than about 20 μ
m;wherein the device is configured to release at least 90% of the drug within 1 day; wherein the device is configured to contact bone; and
,wherein the device is configured to control infection at an orthopedic surgical site. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. An implantable medical device for controlling infection at an orthopedic surgical site and configured to contact bone comprising:
-
an orthopedic device substrate having a metallic surface; a coating on the surface of the metallic substrate, wherein the coating consists essentially of gentamicin sulfate present on the surface of the metallic substrate in a dosage of at least about 400 μ
g·
cm−
2 to not more than about 2000 μ
g·
cm−
2; and
,a protective layer having a thickness of less than 20 μ
m which overlies the coating, the protective layer comprising a lactic acid/glycolic acid copolymer having a weight average molecular weight of not more than 20,000 g/mol, and a molar ratio of lactic acid to glycolic acid of about 50;
50;wherein the device is configured to release at least 60% of the drug within 3 hours; wherein the device is configured to release at least 90% of the drug within 24 hours; wherein the device is configured to contact bone; and
,wherein the device is configured to control infection at an orthopedic surgical site.
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Specification
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Current AssigneeDepuy International Limited (Johnson & Johnson)
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Original AssigneeDepuy International Limited (Johnson & Johnson)
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InventorsLi, Yufu, Schachter, Deborah, Shissias, Raymond S., Wechsler, Sandra
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Primary Examiner(s)Schillinger, Ann
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Application NumberUS13/124,532Publication NumberTime in Patent Office2,993 DaysField of Search623 111- 154US Class CurrentCPC Class CodesA61L 2300/406 AntibioticsA61L 2300/608 having two or more layersA61L 2420/08 Coatings comprising two or ...A61L 31/10 Macromolecular materialsA61L 31/16 Biologically active materia...C08L 67/04 Polyesters derived from hyd...
