Two part antimicrobial boot

#This application relates to medical devices and methods of sterilizing medical devices; particularly drug-containing devices and more particularly minocycline and rifampin-containing devices.

#Implantable medical devices increasingly incorporate drugs to improve the performance of the medical device or reduce side effects associated with implantation of the device. Sterilization processes suitable for medical devices that do not incorporate drugs may not be suitable for such devices that incorporate drugs, due to incompatibilities of the sterilization process and the drugs. Examples of sterilization processes include steam sterilization (e.g., autoclaving), chemical sterilization (e.g., ethylene oxide or vaporized hydrogen peroxide), and sterilization via radiation (e.g., gamma or e-beam). Steam sterilization may not be compatible with drugs that degrade under high temperature or humidity conditions. Chemical sterilization may not be compatible with drugs that have chemical groups that react with the sterilization chemical, such as ethylene oxide. Radiation typically alters the chemical structures of drugs incorporated into medical devices. Accordingly, some drugs may be incompatible with radiation sterilization and may be more or less sensitive to gamma versus e-beam radiation, depending on the nature of the specific drug.

#With regard to radiation sterilization, gamma radiation is capable of penetrating much further into a product or packaging than e-beam radiation because gamma radiation is higher energy radiation than e-beam. As such, gamma radiation may be preferred to e-beam in certain situations where the product is thick or dense and sterility throughout must be demonstrated. However, due to the set up of typical sterilization facilities, products sterilized by gamma radiation may be over sterilized or exposed to gamma radiation for a longer time than is needed to achieve sufficient sterilization. On the other hand, facilities for e-beam sterilization are typically more capable of limiting exposure of a product to the amount of radiation energy necessary to achieve sufficient sterilization. Accordingly, e-beam sterilization can be gentler than gamma radiation to products and their packaging. Regardless of the sterilization process employed, the compatibility of a drug or device with a particular sterilization process should be drug or device dependent if the sterilization level of the process is roughly equivalent.

#FIG. 1 is a diagrammatic illustration of a cross-section of a device comprising therapeutic agent disposed within a polymeric layer of the device.

#FIG. 2 is a diagrammatic illustration of a cross-section of a device comprising therapeutic agent disposed on the surface of a polymeric layer of the device.

#FIG. 3 is a diagrammatic illustration of a cross-section of a device comprising therapeutic agent disposed in an intermediate layer and an outer layer of the device.

#The figures are not necessarily to scale.

#As more medical devices incorporate associated therapeutic agents, the processes for sterilizing such devices should be carefully considered, particularly for devices that contain multiple therapeutic agents. Devices, systems and methods where such consideration has been given are described herein.

#Medical Device