摘要:
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.
摘要:
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.
摘要:
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.
摘要:
An apparatus and method for controlling inflation pressure and pressurization rate of a balloon during deployment of a stent or scaffold is disclosed.
摘要:
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.
摘要:
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.
摘要:
A test fixture for use with a Dynamic Mechanical Analyzer (DMA) restrains a hollow cylindrical tube for purposes of performing either a tensile or transverse/bending load test. The fixture includes a clamp that is configured to restrain the tube without imparting a preload or changing a mechanical property of the tube.
摘要:
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.
摘要:
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.
摘要:
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.