Abstract:
Methods of fabricating an implantable medical devices such as stents made from biodegradable polymers are disclosed that reduce or minimize chain scission and monomer generation during processing steps. The method includes processing a poly(L-lactide) resin having an number average molecular weight between 150 to 200 kD in an extruder in a molten state. A poly(L-lactide) tube is formed from the processed resin and a stent is fabricated from the tube. The number average molecular weight of the poly(L-lactide) of the stent after sterilization is 70 to 100 kD.
Abstract:
Methods to expand polymer tubing with desirable or optimum morphology and mechanical properties for stem manufacture and fabrication of a stent therefrom are disclosed.
Abstract:
Methods and systems for controlling the moisture content of biodegradable and bioresorbable polymer resin during extrusion above a lower limit that allows for plasticization of the polymer resin melt and below an upper limit to reduce or prevent molecular weight loss are disclosed. Methods are further disclosed involving plasticization of a polymer resin for feeding into an extruder with carbon dioxide and freon.
Abstract:
Methods of treating with a biodegradable polymeric stent made from poly(L-lactide) and a low concentration of L-lactide monomer is disclosed. The concentration of L-lactide is adjusted to provide a degradation behavior that is suitable for different treatment applications including coronary, peripheral, and nasal.
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 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:
Methods and systems for controlling the moisture content of biodegradable and bioresorbable polymer resin during extrusion above a lower limit that allows for plasticization of the polymer resin melt and below an upper limit to reduce or prevent molecular weight loss are disclosed. Methods are further disclosed involving plasticization of a polymer resin for feeding into an extruder with carbon dioxide and freon.
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:
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 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.