Abstract:
A method of accelerated aging of bioresorbable polymer scaffolds including exposing the scaffold to water is disclosed. The scaffold is exposed to water at a controlled temperature for a selected aging time. The functional outputs, such as radial strength, expandability, and % recoil obtained from aged scaffolds predict those of real-time aging of the scaffold. The accelerated aging factor, which is the required shelf life divided by the aging time, is significantly higher for poly(L-lactide) scaffolds tested than thermal aging.
Abstract:
A medical device-includes a scaffold crimped to a catheter having an expansion balloon. The scaffold is crimped to the balloon by a process that includes one or more balloon pressurization steps. The balloon pressurization steps are selected to enhance scaffold retention to the balloon and maintain a relatively uniform arrangement of balloon folds about the inner surface of the crimped scaffold so that the scaffold expands in a uniform manner when the balloon is inflated.
Abstract:
A method to reduce or minimize the reduction in molecular weight of a stent during processing is disclosed. The stent has a scaffolding including a polymer formulation comprising PLLA and polymandelide. The polymandelide reduces the molecular weight drop during processing, particularly during sterilization. The stent scaffolding can further include one or more additional stabilizing agents that additionally reduce the molecular weight drop during processing.
Abstract:
A medical device implantable within a peripheral vessel of the body composed of a bioresorbable polymer is disclosed. The device has a high resistance to fracture, is very flexible, and has a high crush recovery when subjected to crushing, axial, or torsional forces.
Abstract:
A stent scaffolding including a polymer formulation comprising PLLA and polymandelide is disclosed. The polymandelide reduces the molecular weight drop during processing, particularly during sterilization. The stent scaffolding can further include one or more additional stabilizing agents that additionally reduce the molecular weight drop during processing.
Abstract:
Methods of controlling the degradation profile of a biodegradable stent scaffolding are disclosed. A bioabsorbable scaffold having a plurality of particles incorporated into the scaffolding that accelerate the absorption of the scaffolding after an induction time during degradation is disclosed.
Abstract:
A method of treating vascular disease in a patient is disclosed that comprises deploying a bioabsorbable polymer scaffold composed of a plurality of struts at a stenotic segment of an artery of a patient, wherein after the scaffold supports the segment at an increased diameter for a period of time the polymer degrades and is progressively replaced by de novo formation of malleable provisional matrix comprising proteoglycan, wherein as the scaffold becomes more malleable and becomes disconnected as it degrades, wherein following coverage of the struts by a neointima layer and loss of mechanical support provided by the scaffold, the scaffold is pulled outward by positive remodeling of the vessel wall of the scaffolded segment.
Abstract:
Methods of fabricating a polymeric implantable device with improved fracture toughness through annealing are disclosed herein. A polymeric construct is annealed with no or substantially no crystal growth to increase nucleation density. After the annealing, crystallites are grown around the formed nuclei. An implantable medical device, such as a stent, can be fabricated from the polymer construct after the crystallite growth.
Abstract:
A polymer endoprosthesis is fabricated by a combination of injection molding and blow molding which form a tubular substrate of polymer material, followed by laser cutting, crimping and sterilization. After the injection and blow molding processes, a subtractive process is performed on the tubular substrate to transform it into a stent having a network of stent struts. The tubular substrate can be made in an injection mold and blow mold which are attached to each other. The transition from injection molding and blow molding can be performed while the injection molded substrate remains at a temperature at or above Tg of the polymer material.