Abstract:
Method is disclosed including thermally processing a scaffold to increase the radial strength of the scaffold when the scaffold is deployed from a crimped state to a deployed state such as a nominal deployment diameter. The thermal processing may further maintain or increase the expansion capability of the scaffold when expanded beyond the nominal diameter.
Abstract:
The present invention relates to implantable medical devices comprising a L-lactide-constitutional unit-containing copolymer having a wt% percent crystallinity of 40% or less.
Abstract:
Methods of fabricating a polymeric implantable device from a PLLA/PDLA blend such as a stent with improved fracture toughness are disclosed. The blend is melt processed to allow formation of stereocomplex crystallites, which are nucleation sites for crystal growth. A polymer construct is formed from the melt processed blend and device is formed from the polymer construct. The stereocomplex crystallites result in an in increase in nucleation density and reduced crystal size, which increases fracture toughness of the formed device.
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:
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:
Bioresorbable polymer vascular scaffolds made of combinations of polylactide and polycaprolactone having thin struts in a selected range and sufficient radial strength to support a vessel upon deployment are disclosed. The scaffolds have degradation behavior of molecular weight, radial strength, and mass that are conducive to healing of a vessel including providing patency to a vessel, reduction of radial strength, breaking up, and resorbing to allow return of the vessel to a natural state.
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 stent manufacture and fabrication of a stent therefrom are disclosed.
Abstract:
A fluid accumulator (130) for controlling inflation pressure and pressurization rate of a stent delivery balloon catheter (120) during deployment of a stent or scaffold (126) are disclosed. The fluid accumulator comprises a chamber (136) connected with an inflation lumen of a balloon (125). A movable wall (138) inside the chamber allows the volume of the chamber to vary in response to pressure of inflation fluid that flows into the chamber. The wall moves against a biasing force that opposes a volume increase of the chamber and thus attenuates the pressure in the chamber.
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.