Biocompatible crosslinked polymers with visualization agents
DCFirst Claim
1. A polymeric coating for a substrate comprising:
- water, a biocompatible visualization agent, and a biodegradable hydrogel, that is essentially completely degradable in vivo by hydrolytic degradation, with the hydrogel having an interior and an exterior, with the exterior having a substrate coating surface, and the visualization agent being at least partially disposed within the interior,wherein the hydrogel comprises chemical groups that are prone to aqueous hydrolysis and is thereby degradable in vitro by exposure to aqueous solution, andwherein the visualization agent has a predetermined concentration that indicates a predetermined thickness of the hydrogel as deposited on the substrate.
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Abstract
Biocompatible crosslinked polymers, and methods for their preparation and use, are disclosed in which the biocompatible crosslinked polymers are formed from water soluble precursors having electrophilic and nucleophilic functional groups capable of reacting and crosslinking in situ. Methods for making the resulting biocompatible crosslinked polymers biodegradable or not are provided, as are methods for controlling the rate of degradation. The crosslinking reactions may be carried out in situ on organs or tissues or outside the body. Applications for such biocompatible crosslinked polymers and their precursors include controlled delivery of drugs, prevention of post-operative adhesions, coating of medical devices such as vascular grafts, wound dressings and surgical sealants. Visualization agents may be included with the crosslinked polymers.
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Citations
38 Claims
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1. A polymeric coating for a substrate comprising:
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water, a biocompatible visualization agent, and a biodegradable hydrogel, that is essentially completely degradable in vivo by hydrolytic degradation, with the hydrogel having an interior and an exterior, with the exterior having a substrate coating surface, and the visualization agent being at least partially disposed within the interior, wherein the hydrogel comprises chemical groups that are prone to aqueous hydrolysis and is thereby degradable in vitro by exposure to aqueous solution, and wherein the visualization agent has a predetermined concentration that indicates a predetermined thickness of the hydrogel as deposited on the substrate. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method of preparing a composition suitable to coat a tissue substrate of a patient, the method comprising:
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mixing reactive precursor species comprising nucleophilic functional groups, reactive precursor species comprising electrophilic functional groups, and at least about 0.1 mg/ml of an unbleached visualization agent such that the nucleophilic functional groups react with the electrophilic functional groups to form covalent bonds and crosslink the reactive precursor species after the mixing to form a covalently crosslinked biodegradable hydrogel contacting the tissue substrate and having an interior and an exterior, with the exterior having at least one tissue substrate coating surface and the visualization agent being at least partially disposed within the interior, wherein the hydrogel comprises chemical groups that are prone to aqueous hydrolysis and is thereby degradable in vitro by exposure to aqueous solution, and wherein the visualization agent has a predetermined concentration that indicates a predetermined thickness of the hydrogel as deposited on substrate. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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25. A method for formulating a polymer composition that crosslinks to form a biodegradable hydrogel that is essentially completely degradable in vivo by hydrolytic degradation, the method comprising selecting a concentration of visualization agent for the polymer composition that results in a visually observable change when the polymer composition is applied to a substrate tissue at a predetermined thickness to form the crosslinked biodegradable bydrogel on the substrate tissue,
wherein the hydrogel comprises chemical groups that are prone to aqueous hydrolysis and is thereby degradable in vitro by exposure to aqueous solution, and wherein the observable change is not being able to see the substrate tissue through the polymer composition, not being able to see patterns in the substrate tissue surface through the polymer composition, the features of the substrate are obscured, or not being able to see the microvasculature on the substrate tissue.
Specification