Hollow stent filled with a therapeutic agent formulation
First Claim
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1. A medical device, the device comprising:
- a device body comprising at least one structural element, the structural element comprising a lumen and at least one opening to access the lumen; and
a composition within the lumen, the composition comprising a therapeutic agent, and a metal ion stabilizer;
wherein the at least one structural element has walls, the walls forming an interior surface and the lumen being surrounded by the interior surface;
wherein the composition comprises at least 0.1 μ
g of the metal ion stabilizer/cm2 of the interior surface surrounding the lumen and not more than 15 μ
g metal of the ion stabilizer/cm2 of the interior surface surrounding the lumen;
andwherein the medical device is a stent.
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Abstract
A composition for loading into a structural element of a stent, where the structural element is defined by a lumen and at least one opening to access the lumen. The composition may comprise a therapeutic agent, and a chelator, a precipitation agent, or a combination thereof. Medical devices, such as stents, with a structural element defined by a lumen and at least one opening to access the lumen, filled with the compositions are also described.
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Citations
25 Claims
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1. A medical device, the device comprising:
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a device body comprising at least one structural element, the structural element comprising a lumen and at least one opening to access the lumen; and a composition within the lumen, the composition comprising a therapeutic agent, and a metal ion stabilizer; wherein the at least one structural element has walls, the walls forming an interior surface and the lumen being surrounded by the interior surface; wherein the composition comprises at least 0.1 μ
g of the metal ion stabilizer/cm2 of the interior surface surrounding the lumen and not more than 15 μ
g metal of the ion stabilizer/cm2 of the interior surface surrounding the lumen;and wherein the medical device is a stent. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A stent comprising:
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a plurality of interconnected structural elements comprising a metallic material, wherein at least some of the structural elements are annular and comprise an interior lumen; and a therapeutic agent and an additive disposed within the interior lumen(s); wherein an inner surface of the annular structural element(s) is susceptible to release of metal ions which are capable of degrading the therapeutic agent; wherein the additive is for protecting the therapeutic agent from degradation by the metal ions by rendering the metal ions unable to interact with the therapeutic agent; wherein the additive is present at an amount of at least 0.1 μ
g/cm2 of the inner surface and not more than 15 μ
g/cm2 of the inner surface; andwherein the additive is selected from the group consisting of 2,3-dimereapto-1-propanesulfonic acid, dimercaptosuccinic acid, dimercaprol, desferrioxamine mesylate, alpha lipoic acid, nitrilotriacetate, thiamine tetrahydrofurfiuyl disulfide, deferiprone, deferasirox, kojic acid, bisphosphonates, 3-hydroxy-4-pyridinecarboxylic acid, 4-hydroxy-3-pyridinecarboxylic acid, 1,6-Dimethyl-4-hydroxy-3-pyridinecarboxylic acid, 4-hydroxy-2-methyl-3-pyridinecarboxylic acid, desferrioxamine, succinic acid, sodium, calcium, and magnesium salts of succinic acid, feralex-G, clioquinol, epigallocatechin, 3-hydroxy-4-pyridinone, stearic acid, lauric acid, capric acid, and caprylic acid, and sodium, calcium, and magnesium salts of stearic acid, lauric acid, capric acid, and caprylic acid, and combinations thereof. - View Dependent Claims (17, 18, 19)
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20. A stent comprising:
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a plurality of interconnected structural elements comprising a metallic material, wherein at least some of the structural elements are annular and comprise an interior lumen; and a therapeutic agent and an additive disposed within the interior lumen(s); wherein an inner surface of the annular structural element(s) is susceptible to release of metal ions which are capable of degrading the therapeutic agent; wherein the additive is for protecting the therapeutic agent from degradation by the metal ions by rendering the metal ions unable to interact with the therapeutic agent; wherein the additive is present at an amount of at least 0.1 μ
g/cm2 of the inner surface and not more than 15 μ
g/cm2 of the inner surface; andwherein the annular structural elements comprising the interior lumen are tubes formed from tube stock with the interior lumen of essentially uniform cross-sectional area and the tubes comprising one or more side openings to access the interior lumen and allow the therapeutic agent to be released from the interior lumen, and the side openings have a cross-sectional area of not more than 10% of the cross-sectional area of the lumen of the tube stock from which the annular structural element was formed.
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21. A method comprising:
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providing a medical device having a structural element, the structural element comprising a lumen and at least one opening to access the lumen; filling the lumen of the structural element with a composition comprising a therapeutic agent and a metal ion stabilizer; wherein the at least one structural element has walls, the walls forming an interior surface, and the lumen being surrounded by the interior surface; wherein the composition comprises at least 0.1 μ
g of the metal ion stabilizer/cm2 of the interior surface surrounding the lumen and not more than 15 μ
g of the metal ion stabilizer/cm2 of the interior surface surrounding the lumen;and wherein the medical device is a stent. - View Dependent Claims (22, 23, 24, 25)
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Specification