Abstract:
A medical device includes a tubular network of struts including a bioerodible polymer. The tubular network can include a plurality of bands and a plurality of connector struts. Each band can include a plurality of peaks between adjacent band struts. Each band can be connected to one or more adjacent bands by at least two connector struts at a plurality of connector intersections. The bioerodible polymer can include a plurality of polymer chains functionalized with a photo active group.
Abstract:
The present disclosure provides methods for reducing bioburden on a tissue product, as well as the tissue products produced according to the disclosed methods. In particular, the disclosure relates to methods of electroporating tissue in the presence of one or more bactericides in order to reduce bioburden. The methods allow for reduced exposure to electrical energy and/or bactericide while reducing bioburden.
Abstract:
The invention relates to fluoropolymer articles that have been irradiated with at least 5 Kilo Gray of radiation, where the resulting articles have low levels of leachable or extractable fluoride ion. The low fluoride ion migration from the irradiated article is due to the presence of low levels of metallic salts or oxides in the fluoropolymer composition. The invention is especially useful for fluoropolymer articles in which the fluoropolymer layer contacts a biological or pharmaceutical fluid, and that are subjected to sterilization by irradiation.
Abstract:
The invention relates to fluoropolymer articles that have been irradiated with at least 5 Kilo Gray of radiation, where the resulting articles have low levels of leachable or extractable fluoride ion. The low fluoride ion migration from the irradiated article is due to the presence of low levels of metalic salts or oxides in the fluoropolymer composition. The invention is especially useful for fluoropolymer articles in which the fluorpolymer layer contacts a biological or pharmaceutical fluid, and that are subjected to sterilization by irradiation.
Abstract:
A system for sterilizing a fluid includes a fluid source and a sterilization container bounding a fluid flow path that is in fluid communication with the fluid source. The sterilization container is comprised of one or more polymeric walls. An electron beam generator is configured to direct an electron beam through at least a portion of the fluid flow path of the sterilization container, the electron beam being sufficient to sterilize a fluid within the fluid flow path.
Abstract:
Tissue and other body structures may be protected using a hydrated composition made from free-flowing substantially collagen-free rehydratable polysaccharide particles and rehydratable polysaccharide sponges. Rehydration of the particles without clumping may be carried out be dispersing the particles in a biocompatible water-miscible polar dispersant such as ethanol and combining the dispersion with sufficient aqueous solvent for the particles to convert them to a cohesive hydrogel. The hydrated composition may assist in returning an injured, inflamed or surgically repaired surface to a normal state, e.g., through one or more healing mechanisms such as modulation of an inflammatory response, phagocytosis, mucosal remodeling, reciliation or other full or partial restoration of normal function.
Abstract:
Methods are disclosed for conditioning a polymeric stent after sterilization, and/or after crimping and before packaging, such that the properties of the polymeric stent fall within a narrower range of values. The stent is exposed to a controlled temperature at or above ambient for a period of time after radiation sterilization and/or after crimping and before sterilization. As a result, the polymeric stent properties, particularly radial strength and number-average molecular weight of the polymer of the polymeric stent, fall within a narrower range.
Abstract:
The present application is directed to methods of sterilizing bendamustine and its pharmaceutically acceptable salt forms. Preferred sterilization methods include dry heat sterilization, gamma irradiation, and e beam radiation. Sterile pharmaceutical compositions are also described.
Abstract:
A method and an arrangement for sterilizing, in particular for sterilizing an adsorber, which has an adsorber housing that is to be filled with an adsorbent, are such that, instead of the adsorbent-filled adsorber housing being sterilized, the adsorbent is sterilized in a separate container, which is dimensioned such that the adsorbent spreads out in a thin layer in the container. Together with the adsorber housing, the container for sterilizing the adsorbent forms a closed system, such that the adsorbent can be transferred into the adsorber housing without the need for an aseptic environment. The container for receiving the adsorbent is preferably a bag, in which the adsorbent spreads out in a thin layer when the bag is lying flat on a plane surface. Since the adsorbent in the bag spreads out in a thin layer, the sterilization requires only a relatively small dose of radiation, which cannot damage the adsorbent. The bag is irradiated with high-energy radiation, in particular ionizing radiation. The adsorbent is then transferred from the bag into the adsorber housing. During the transfer of the adsorbent into the adsorber housing, the air and/or excess liquid present in the adsorber housing is removed from the adsorber housing preferably into one or more empty bags.
Abstract:
Methods are disclosed for conditioning a polymeric stent after sterilization, and/or after crimping and before packaging, such that the properties of the polymeric stent fall within a narrower range of values. The stent is exposed to a controlled temperature at or above ambient for a period of time after radiation sterilization and/or after crimping and before sterilization. As a result, the polymeric stent properties, particularly radial strength and number-average molecular weight of the polymer of the polymeric stent, fall within a narrower range.