Drug-releasing coatings for medical devices
First Claim
1. A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising:
- a) forming a reservoir layer over the surface by applying a reservoir layer composition comprising a polymer and a biologically active material andb) forming an outer layer over the reservoir layer by applying an outer layer composition comprising an ionic surfactant complexed to the biologically active material.
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Abstract
The invention is directed to medical devices having a drug-releasing coating and methods for making such coated devices. The coating permits timed or prolonged pharmacological activity on the surface of medical devices through a reservoir concept. Specifically, the coating comprises at least two layers: an outer layer containing at least one drug-ionic surfactant complex overlying a reservoir layer containing a polymer and the drug which is substantially free of an ionic surfactant. Upon exposure to body tissue of a medical device covered with such coating, the ionically bound drug in the outer layer is released into body fluid or tissue. Following release of such bound drug, the ionic surfactant binding sites in the outer layer are left vacant. To maintain the pharmacological activity after delivery of the ionically bound drug, additional amounts of the drug are embedded or incorporated in the reservoir layer in a manner which allows the drug, which is substantially free of ionic surfactants, to complex with the vacant binding sites of the ionic surfactant of the outer layer. As a result, the surface of the medical device is enriched with the drug to provide sustained pharmacological activity to prevent the adverse reaction due to the presence of the medical device. The invention is further directed to medical devices with stabilized drug-releasing coatings. The coatings are stabilized by exposure to a low energy, relatively non-penetrating energy source, e.g., gas plasma or an electron beam energy source.
785 Citations
42 Claims
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1. A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising:
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a) forming a reservoir layer over the surface by applying a reservoir layer composition comprising a polymer and a biologically active material and b) forming an outer layer over the reservoir layer by applying an outer layer composition comprising an ionic surfactant complexed to the biologically active material. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 22)
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19. A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comnprising:
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a) forming a reservoir layer over the surface by applying a reservoir layer composition comprising a polymer and a biologically active material; b) forming an outer layer over the reservoir layer by applying an outer layer composition comprising an ionic surfactant complexed to the biologically active material; c) heat curing the reservoir layer composition after it is applied to the surface; and d) treating the reservoir layer with a low energy, relatively non-penetrating energy source.
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21. A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising:
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a) forming a reservoir layer over the surface by applying a reservoir layer composition comprising a polymer and a biologically active materiall b) forming an outer layer over the reservoir layer by applying an outer layer composition comprising an ionic surfactant complexed to the biologically active material; c) treating the coating with a low energy, relatively non-penetrating energy source after the forming of the outer layer; and d) heat curing the coating before the coating is treated with the energy source.
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23. A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising:
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a) forming a layer of the coating which comprises an ionic surfactant completed to the biologically active material on the surface, and b) exposing the layer to a low energy, relatively non-penetrating energy source. - View Dependent Claims (24, 27, 28, 29)
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25. A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising:
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a) forming a layer of the coating which comprises an ionic surfactant complexed to the biologically active material on the surface, and b) exposing the layer to a low energy, relatively non-penetrating energy source;
wherein the surface covered with the layer is heated at about 40°
C. to 150°
C. prior to exposing the coated surface to the low energy, relatively non-penetrating energy source. - View Dependent Claims (26)
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30. A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising:
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a) forming a first layer of the coating over the surface by applying a first layer composition comprising a polymer, b) forming an outer layer over the first layer by applying an outer layer composition comprising an ionic surfactant complexed to the biologically active material, and c) exposing the coated surface to a low energy, relatively non-penetrating energy source. - View Dependent Claims (31, 32, 35, 36, 37, 38, 39, 40, 41, 42)
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33. A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising:
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a) forming a first layer of the coating over the surface by applying a first layer composition comprising a polymer, b) forming an outer layer over the first layer by applying an outer layer composition comprising an ionic surfactant complexed to the biologically active material, and c) exposing the coated surface to a low energy, relatively non-penetrating energy source;
wherein the coated surface is heated at about 40°
C. to 150°
C. prior to exposing the coated surface to the low energy, relatively non-penetrating energy source. - View Dependent Claims (34)
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Specification