Medical implants and methods of making medical implants
First Claim
1. A medical implant device comprising:
- a device substrate having a surface;
a silane derivative coating comprising a terminal amine, wherein the silane derivative coating is covalently bonded to the surface;
a bioactive agent; and
a hetero-bifunctional polyethylene glycol spacer comprising a carboxyl group and an amine group;
wherein the spacer is between the silane derivative coating and the bioactive agent, the carboxyl group of the polyethylene glycol spacer being covalently bonded to the terminal amine of the silane derivative coating through a peptide bond and the amine group of the polyethylene glycol spacer being covalently bonded to the bioactive agent through a peptide bond;
wherein the silane derivative coating is first bonded to the surface before bonding to the polyethylene glycol spacer.
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Accused Products
Abstract
A medical implant device having a substrate with an oxidized surface and a silane derivative coating covalently bonded to the oxidized surface. A bioactive agent is covalently bonded to the silane derivative coating. An implantable stent device including a stent core having an oxidized surface with a layer of silane derivative covalently bonded thereto. A spacer layer comprising polyethylene glycol (PEG) is covalently bonded to the layer of silane derivative and a protein is covalently bonded to the PEG. A method of making a medical implant device including providing a substrate having a surface, oxidizing the surface and reacting with derivitized silane to form a silane coating covalently bonded to the surface. A bioactive agent is then covalently bonded to the silane coating. In particular instances, an additional coating of bio-absorbable polymer and/or pharmaceutical agent is deposited over the bioactive agent.
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Citations
34 Claims
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1. A medical implant device comprising:
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a device substrate having a surface; a silane derivative coating comprising a terminal amine, wherein the silane derivative coating is covalently bonded to the surface; a bioactive agent; and a hetero-bifunctional polyethylene glycol spacer comprising a carboxyl group and an amine group; wherein the spacer is between the silane derivative coating and the bioactive agent, the carboxyl group of the polyethylene glycol spacer being covalently bonded to the terminal amine of the silane derivative coating through a peptide bond and the amine group of the polyethylene glycol spacer being covalently bonded to the bioactive agent through a peptide bond;
wherein the silane derivative coating is first bonded to the surface before bonding to the polyethylene glycol spacer. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 18, 19)
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10. An implantable stent device comprising:
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a stent core having a surface; a layer of silane derivative comprising a terminal amine covalently bonded to the surface; a spacer layer comprising a hetero-bifunctional polyethelene glycol (PEG) derivative comprising a carboxyl group and an amine group wherein the spacer is between the silane derivative and a protein, the carboxyl group of the spacer being covalently bonded to the terminal amine of the silane derivative through a peptide bond; and
a protein covalently bonded to the PEG amine group through a peptide bond;
wherein the silane derivative is first bonded to the surface before bonding to the polyethylene glycol spacer. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17)
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20. A method of making a medical implant device, comprising:
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providing a device substrate having a surface; oxidizing the surface to produce an oxidized surface; reacting the oxidized surface with derivitized silane comprising a terminal amine to form a silane coating over the surface, the coating being covalently bonded to the surface; providing a bioactive agent; and covalently bonding heterobifunctional polyethylene glycol comprising a carboxyl group and an amine group, the carboxyl group of the spacer being covalently bonded to the terminal amine of the derivitized silane surface through a peptide bond and the amine group of the polyethylene glycol covalently bonded to the bioactive agent to form a polyethylene glycol spacer between the derivitized silane and the bioactive agent. - View Dependent Claims (21, 22, 23, 24, 25, 26)
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27. A medical implant device comprising a stent;
- at least one silane derivative comprising a terminal amine covalently bonded to a surface of the stent;
a bioactive agent; and
a hetero-bifunctional polyethylene glycol spacer comprising a carboxyl group and an amine group between the silane derivative coating and the bioactive agent, the carboxyl group of the polyethylene glycol spacer being covalently bonded to the terminal amine of the silane derivative coating through a peptide bond and the amine group of the polyethylene glycol spacer being covalently bonded to the bioactive agent through a peptide bond;
further comprising a plurality of layers that form a laminate coating on said stent;
wherein at least one of said layers comprises a bioabsorbable polymer and at least one of said layers comprises a pharmaceutical agent selected from the group consisting of rapamycin, a prodrug, a derivative, a hydrate, an ester, and a salt thereof;
wherein at least a portion of the pharmaceutical agent is in crystalline form;
wherein the silane derivative coating is first bonded to the surface of the stent before bonding to the polyethylene glycol spacer. - View Dependent Claims (28, 29, 30, 31, 32, 33, 34)
- at least one silane derivative comprising a terminal amine covalently bonded to a surface of the stent;
Specification