Medical implants and methods for regulating the tissue response to vascular closure devices

摘要

Devices and methods for reducing, eliminating, preventing, suppressing, or treating tissue responses to hemostatic devices e.g., biological sealants or vascular procedures are disclosed. The invention employs a combination of resorbable, biocompatible matrix materials and a variety of therapeutic agents, such as antiproliferatives or antibiotics, applied to a vascular puncture or incision to achieve hemostasis following diagnostic or interventional vascular catheterizations and to treat neointimal hyperplasia and stenosis. A matrix of a material such as collagen provides a reservoir of a therapeutic agent such as rapamycin (sirolimus) and its derivatives and analogs for delivery at a tissue site at risk for vasculoproliferation, infection, inflammation, fibrosis or other tissue responses.

主权项

1. A method of treating a site of vascular compromise in a target vessel to seal a puncture or opening, and treat, suppress or prevent a tissue response at such site resulting from the sealing of the puncture or opening, comprising the steps of:
combining a tissue response regulating amount of rapamycin and a hemostatic material comprising a sheet of collagen, wherein the sheet of collagen is either impregnated, absorbed, adsorbed, saturated, dispersed or immobilized with rapamycin in an amount of about 0.2 μg/cm2 to 2.0 mg/cm2 of the collagen and has an effective pore size from about 0.001 to 100 μm, and wherein the hemostatic device is configured to be perivascularly applied around the outer circumferential surface of the target vessel at the site of the vascular compromise; and applying the combination perivascularly to the target vessel at the site of vascular compromise such that the combination is placed over and around an outer circumferential surface of the target vessel, seals the puncture or opening, and elutes the rapamycin to the target vessel over the substantial length of the hemostatic device.