Films and methods of manufacture

摘要

A flexible body comprises a polymer film having a first surface and an opposing second surface. The polymer film has a plurality of apertures extending from the first surface to the second surface and a plurality of raised lips protruding from the first surface such that each of the plurality of apertures is surrounded by one of the plurality of raised lips. A method of producing a polymer film comprises placing a polymer solution into a one sided mold having a plurality of protrusions extending from a bottom of the mold wherein the polymer solution is characterized by a viscosity that inhibits the unaided flow of the polymer throughout the mold; urging the polymer solution around each of the plurality of protrusions; and solidifying the polymer solution.

主权项

1. An implantable medical device comprising:
a flexible polymer film having a first surface and an opposing second surface, the polymer film having a plurality of apertures extending from the first surface to the second surface and a plurality of raised lips protruding from the first surface, wherein each one of the plurality of lips is continuous with and surrounds one of the plurality of apertures; wherein the film includes a plurality of discrete eluting drug components disposed within the film, the plurality of discrete eluting drug components have an average diameter under 10 microns and comprising at least an antibiotic active against orthopedic implant related infections; wherein the polymer film elutes the antibiotic from the discrete eluting drug components in a two phase release process including a burst release process upon exposure to water or a body fluid, and a controlled release process, wherein the burst release process releases about 20% to 35% of the total content of the antibiotic, and the two phase release process releases the total content of the antibiotic within a three-week period.