Free-standing biodegradable patch
First Claim
1. A device for treatment comprising:
- a film that is biocompatible, biodegradable, and adapted to adhere to tissue at or adjacent to a sinus of a patient, the film integrally formed, prior to adherence to the tissue, of at least a first adhesive layer comprising an amount of unreacted, purified human fibrinogen prepared without excipients selected to transition the film to a temporary gel state upon exposure to an aqueous environment, the first adhesive layer adjoined to a second layer comprising and a therapeutic agent configured to be released into the tissue, the first adhesive layer further comprising a plasticizer in an amount of up to 0.5 mg per mg of fibrinogen,wherein, in the temporary gel state, the film is freely manipulatable and deformable to adhere to the tissue.
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Accused Products
Abstract
Methods and apparatus for a free-standing biodegradable patch suitable for medical applications, especially intravascular, minimally-invasive and intraoperative surgical applications are provided, wherein the patch comprises a free-standing film or device having a mixture of a solid fibrinogen component and a solid thrombin component that, when exposed to an aqueous environment, undergoes polymerization to form fibrin. In alternative embodiments the patch may comprise a solid fibrinogen component, with or without an inorganic calcium salt component. The patch may take a non-adherent form during delivery to a target location within a vessel or tissue, and thereafter may be activated to adhere to vessel wall or tissue, and may include a number of additives, including materials to improve the mechanical properties of the patch, or one or more therapeutic or contrast agents.
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Citations
15 Claims
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1. A device for treatment comprising:
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a film that is biocompatible, biodegradable, and adapted to adhere to tissue at or adjacent to a sinus of a patient, the film integrally formed, prior to adherence to the tissue, of at least a first adhesive layer comprising an amount of unreacted, purified human fibrinogen prepared without excipients selected to transition the film to a temporary gel state upon exposure to an aqueous environment, the first adhesive layer adjoined to a second layer comprising and a therapeutic agent configured to be released into the tissue, the first adhesive layer further comprising a plasticizer in an amount of up to 0.5 mg per mg of fibrinogen, wherein, in the temporary gel state, the film is freely manipulatable and deformable to adhere to the tissue. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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Specification