Free-standing biodegradable patch
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.
1. A method of delivering a patch to bodily tissue, comprising:
advancing a free-standing film comprising unreacted fibrinogen and a plasticizer that comprises about 5 to about 30 weight percent polyethylene glycol to a target location within a body;
exposing the film to moisture in the body while applying the film to a bodily tissue, during which the film forms an adherent patch.
2. The method of claim 1 , wherein the target location is a blood vessel and the bodily tissue is a blood vessel wall.
3. The method of claim 2 , wherein advancing the film comprises advancing the film using a delivery system.
4. The method of claim 3 , wherein applying the film to the bodily tissue further comprises expanding an expandable member of the delivery system.
5. The method of claim 1 , further comprising providing the film wrapped around an expandable member having a water-soluble protective layer.
6. The method of claim 1 , wherein the film further comprises one or more therapeutic agents, the method further comprising delivering the one or more therapeutic agents to the bodily tissue.
7. The method of claim 1 , wherein the film further comprises a radiopaque band, the method further comprising applying the film to a bodily tissue under fluoroscopic guidance.
8. The method of claim 1 , wherein the target location comprises a sinus.
9. The method of claim 1 , wherein the target location comprises an esophagus, stomach, intestine, bronchi, trachea, urethra, ureter, ear, or heart.